Current Trends in Planning Preparation and Delivering Regulatory Submission Through Various Electronic Common Technical Document Software

Technical Review Article | Open Access | Published 2nd April 2025

Current Trends in Planning Preparation and Delivering Regulatory Submission Through Various Electronic Common Technical Document Software

Gaganashree T V,¹ Balamuralidhara V², Chinmayee U Gowda¹ | EJPPS | 301 (2025) https://doi.org/10.37521/30104 | Click to download

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Abstract

The pharmaceutical sector is growing more and more keen on the subject of Electronic Common Technical Documentation (eCTD). An "Electronic Common Technical Document" is a regulatory information transfer link for the pharmaceutical industry (eCTD). The option to submit an eCTD simultaneously with a paper submission (Common Technical Document) has been available to applicants since June 2003, when the eCTD Specification document is accepted at Step 4 by the International Conference on Harmonization Steering Committee. For both medication manufacturers and regulators, it is intended to make regulatory filings simpler and more effective. There are still variances across nations and even ICH areas when it comes to eCTD submission. Electronic submissions will offer uniformity, which will enable much better consistency for both businesses and regulators. It is crucial to create eCTD ready papers by using eCTD compliant templates while writing them. Document reformatting consumes a significant portion of time during the transformation from paper-based to electronic CTD submissions. If not done correctly, regulatory authorities may encounter various issues, which can affect compliance and delay the approval process. History of eCTD, advantages of implementation, difficulties with modules, risks associated with eCTD publication, and quality control are all covered in this article.

Keywords: Dossier, eCTD, History, Modules, Regulatory, Issues.

INTRODUCTION

Pharmaceutical Dossier

The meaning of a dossier in English is a collection or file of materials about a certain subject, particularly one that contains extensive information about a person or issue. A pharmaceutical product for human use refers to any preparation designed for administration to humans, with the purpose of modifying or investigating pathological conditions or physiological systems for useful of the patient. A pharmaceutical product's dossier, which contains all pertinent administrative, chemical, preclinical, and clinical data as well as the approval given by a country's regulatory bodies to support approved or manufacturing in that country, it is critically examined and evaluated as part of the "marketing approval or registration," "marketing authorization," or "product licensing" process.

A pharmaceutical product's "Registration Dossier" is a document that includes technical information (quality administrative, clinical and non-clinical) necessary for the medication to be authorized, registered, and marketed in a certain nation. While the United States and the European Union refer to it as a New Drug Application (NDA) or a Marketing Authorization Application (MAA), other countries more frequently refer to it as a Registration Dossier (EU).

It is available in a variety of formats, including CTD, e-CTD, ACTD, and CTD, and it serves as a template for presenting data in the ICH areas in accordance with the specifications. In the following situations, a generic drug product and an innovator drug product are comparable: the dosage form, the strength, the administration route, the quality, the use, etc.¹

As a result, a dossier is a file document that must be provided in order to comply with the requirements of the procedure for medication approval and market authorization. It is a thorough scientific report that various health authorities use to provide a medicine market authorization or worldwide licensee permission. The regulatory affairs department is responsible for its production, processing, compilation, and dispatch to the field. These tasks are interdependent, and the filing and authorization procedure in developing markets will vary by location.

The necessity to unify regulatory requirements of various nations as well as suggestions for the development of new medications has arisen as a result of the pharmaceutical industry's globalization. A standard submission format will thus aid in removing these obstacles. The ICH process was used to establish the CTD recommendations for Japan, the European Union, the United States. Over all countries have implemented the CTD format².#

HISTORY OF eCTD

Future electronic submission methods may not maintain the homogeneity of the outdated "paper" submission approach (six standards over the past two decades - SEDAMM, MERS, MANSEV, CANDA, DAMOS, eCTD). ICH countries can now receive information by paper, electronic, or non-eCTD electronic Submissions (NeeS). There are many more electronic and print format options available for submissions to non-ICH nations. From the late 1980s, the idea of electronic regulatory filings has developed in both America and Europe. The Food and Drug Administration (FDA) and other organizations have been using electronic submissions for more than 10 years.

The FDA in the US unveiled CANDA in 1985. (Computer-Assisted New Drug Application). It was viewed as a means of giving FDA reviewers instant access to both the report and the data, both of which were in a format that permitted quick and effective data analysis. Regulator reviewers were, unfortunately, forced to use stand-alone desktop computers at their workstations for the majority of the unique and proprietary CANDA formats developed during the CANDA period. There are several distinct CANDA processes that range in complexity from straightforward to sophisticated. Few reviewers have the time to complete the difficult chore of getting acquainted with each new CANDA approach for obtaining the data.

CANDA structural standards, a standard programming environment, and a consistent data file format were non-existent. The outcomes were inconsistent; although many sponsors and reviewers valued the quick review that CANDAs offered, others refused to be educated on and utilize many systems, sometimes concurrently. The FDA promptly ended the unstructured CANDA period. But the submission of electronic data did not end here.

The European regulatory body DAMOS, or Drug Application Methodology with Optical Storage, was introduced in 1989.

SEDAMM, which stands for Submission electronic marketing authorization dossiers, was established by the France in the year 1993.

The Multiagency Electronic Regulatory Submission Project, often known as MERS, was launched by Australia, New Zealand, and the United States in 1994.

The UK, Denmark, France, Italy, and EMEA introduced MANSEV, or Market Authorization by Network Submission and Evaluation, in 1997³.

The ICH M4 (CTD) guideline, which specifies the ideal standard format for the development of applications, should be reported to the regulatory authorities, and the ICH M2 Expert Working Group (EWG) initiated close collaboration in 1997. The first stages of a new electronic submission method were concurrently disclosed by the FDA. The Prescription Drug User Fee Act (PDUFA) efforts from 1992, which required a speedier review process in response to the growing quantity of NDAs, compelled the FDA to develop a technique for the productive assessment of electronic data.

FDA was searching a route to deal with growing stacks of the paper in its file cabinets additionally practical difficulty for assigning regulatory submission sections to the appropriate reviewers. Via a variety of guidance documents, the government planned to fully explain the format and technologies were appropriate for electronic submissions. Thus reviewers could rest easy knowing that any data submitted electronically would be viewable in a recognizable manner, FDA could then guarantee a standard group of electronic submission documents. The FDA therefore released the eNDA and eANDA Guidelines in 2002.

The electronic filing of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) papers quickly replaced manual printing, duplication, pagination, and other procedures, and quickly became the rising norm for many pharmaceutical sponsors. The approval of ICH eCTD Guideline v3.0 on electronic Common Technical Document (eCTD), which is the electronic equivalent of CTD, in 2003 marked a crucial turning point (CTD - a harmonized structure and format for regulatory submissions).

After the launch of eCTD by ICH, which marks the beginning of the change to standards-based submission, all application types, including IND, NDA, BLA, ANDA, and Master Files, are supported. The Enda and eANDA guidance’s were subsequently discontinued in 2006, and in 2004 all ICH regions accepted the ICH eCTD Guideline v3.2. 3 It should be emphasized, nevertheless, that there are still differences in eCTD submission between the countries and ICH regions. For instance, in 2003, FDA started to accept eCTD submissions.

While the heads of the EU's pharmaceuticals agencies pledged in 2005 that they would be ready for eCTD submissions by 2010, Japan began accepting in 2004. The various health organizations still employ distinct strategies. While Japan has recognized eCTD since 2004, it does not permit eCTD submissions of dossiers including active pharmaceutical ingredients (APIs), whereas some agencies in Europe still need paper submissions for some components. Outside of the ICH zone, the eCTD programmed is still being accepted, and in time, non-ICH countries may adopt it as standard practice.

From 2010, applications submitted to the European Medicines Agency (EMA) via the Centralized Process have had to adhere to the eCTD, a universal standard. The format's adoption in Canada, Japan, and other developed countries throughout the world is also heavily marketed. So, familiarity with the format is required for anybody who works on drug regulatory applications. For every New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications in the US, the eCTD format is now required under the Food and Drug Administration Safety and Innovation Act (FDASIA), which was amended and reauthorized in 2012. (ANDAs).

Depending on when the FDA completes the draught guidance document, it will also be essential for the bulk of Investigational New Drug Applications (INDs) during upcoming several years. U.S. Food & Drug Administration on May 5, 2015 has issued a final, legally binding advice document that required some submissions to be completed in eCTD format within 24 months. May 5, 2017 is the projected deadline for electronically submitting biologic license applications (BLAs), new drug applications (NDAs), drug master files. (DMFs), and abbreviated new drug applications (ANDAs),⁴

COMMON TECHNICAL DOCUMENT

CTD is a group of recommendations for the application dossiers for registration of pharmaceuticals for use in the US, Europe, and Japan. It was created by the FDA, the Ministry of Health, Labor, and Welfare (Japan), and the European Medicines Agency (EMA, Europe). The CTD is preserving by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Regulatory review procedures have altered as a result of the dedication to universally collect all quality, safety, and effectiveness details.

Joint regulatory agencies of CTD

Food and Drug Administration (FDA, USA).
European Medicines Agency (EMEA, Europe).
Ministry of Health, Labour and Welfare (MHLW, Japan).

General consideration for CTD

Information must only be given to relevant regulatory organizations in a uniform format, according to CTD.

A format for displaying the data in the dossier.
A recommendation for a standard format for the gathered data alone.

A data declaration for information application is not what a CTD is.

An instruction intended to outline the required research.
Identify the topic.

CTD should be –

Have information that is unambiguous and clear.
Be easy to read and have a large enough font size and style.
Comply to the ICH's advice on document separation and pagination.

CTD submission guidelines/methodology.

Listed at the conclusion of the dossier all abbreviations that are used.
Provide accurate information on the source of the drug(s) in bulk used to make the final formulation.⁵

Regulation & regulatory bodies of CTD

The requirements for approving an application to import or produce an original medication for marketing are outlined in Appendices I, IA, and VI of Schedule Y as well as regulations under the Pharmaceuticals and Cosmetics Act and Regulations 122A, 122B, and 122D.
Each nation has a regulatory body tasked with enforcing laws and issuing directives pertaining to pharmaceutical product development, licensing, registration, manufacture, marketing, and labelling.
Nearly every sovereign nation in the globe has its own regulatory bodies.

CTD STRUCTURE

CTD is structured into five modules. Module 1 is region-specific, with its content defined by regional authorities to align with local requirements. In contrast, Modules 2-5 are standardized and applicable across all ICH member countries.

conceptual structure of CTD The ICH M4 guidelines1 thoroughly outline the CTD's overall layout and provide guidance on where to insert documents and how many pages should be in each one. This information is especially beneficial if dossier has many signs or different sections of investigational pharmaceutical product (IMP).

In addition to M4 criteria, the list of queries and responses is delivered address the most common issues mentioned.

CTD dossier parted into five important modules (Figure 1):

Module 1: Administrative and prescribing information

Module 2: overview and summaries of module 3-5

Module 3: quality (pharmaceutical documentation)

Module 4: non clinical reports (pharmacology/toxicology)

Module 5: clinical study reports (clinical trials)⁶

ACTD

The ACTD is a dossier for the ASEAN region's marketing authorization of pharmaceutical, biological, and biotechnological products. It is divided into 4 separate parts, referred to as Part 1, Part 2, Part 3, and Part 4. Part I contains administrative data and an overview of the product. Information about the drug substance and drug product's quality is provided in Part II. A component of this is entirely devoted to QOS, while another section is devoted to information of the drug substance and drug product. Part IV gives the product's clinical profile while Part III provides the product's nonclinical profile. Part II is the most crucial section for generic products. Part III is essentially optional. When it comes to BE studies, the part IV is necessary.

ACTD Format consists of Four Parts namely.

Part 1: Table of content, prescribing information and administrative information

Part 2: Quality document

Part 3: document of non–clinical data

Part 4: document of clinical data

Summary

It's crucial to gather the necessary documents in accordance with the standards of the harmonized nations, that adhere to ASEAN Guidelines and Format for the registration of pharmaceutical products in their individual nations and regions, in order to create a dossier in the ACTD format.⁷

Requirement - ASEAN

Agreed “ACTR, ACTD, Technical guidelines”

ACTR (ASEAN common Technical Requirement).
ACTD (ASEAN Common Technical Dossier)
Technical “Quality, Safety, Efficacy” guidelines – adopted guidelines (from WHO, ICH, and IP).

Fig 02 – Structure of ACTD

CTD STRUCTURE

CTD is organized into five modules. Since Module 1

is region specific, its content is specified by regional

agencies so as to customize according to the regional

requirements. However, Modules 2-5 are common for

ICH on CTD, enlisted in Table 1.

For processing an application, there are certain general

principles to be followed by applicant. Applicant should

be open and transparent in providing information

and data in CTD. Application should not hide any

information from the regulatory agencies. CTD is to be

prepared as per the guidelines given by ICH. CTD is

eCTD (Electronic common technical document)

The eCTD is a common format for providing regulatory data to the appropriate health authorities, such as applications, supplements, and reports (HAs). It offers a standardized approach to electronically implementing common technical documents. An eCTD is made up of distinct PDF documents that are organized hierarchically in accordance with the CTD structure. Additionally, it contains an XML backbone that ties together necessary documents and offers details about the submission. The introduction of eCTD was done to lighten the workload of the Has' reviewers. Because it is a uniform format used by all regulatory agencies, it also makes the filing process simpler.⁸

Five modules in eCTD as mentioned here

Region specific information
Summary documents
Information related to quality
Non clinical study reports
Clinical study reports (CSRs)

eCTD submissions are accepted for the following applications

Investigational new drug (INDs)
New drug application (NDAs)
Abbreviated new drug application (ANDAs)
Biological license application (BLAs)
All the application following submission of above stated applications.
All the master files (MFs) which are part of any above stated applications

Content specification– as defined by ICH specified below

1. Technical specification- Electronic software’s

2. CTD TOC [pdf][paper]

3. eCTD XML Backbone

eCTD, or electronic CTD, is an XML file (Extensible Mark-up Language) that connects to other files and further metadata, including checksum details, to define the structure of the submittal.

1. The XML schema is quite inflexible.

2. Simple to share and evaluate.

3. A more cost- and stress-effective use of the organization's resources.

4. Self-affirming

eCTD CHARACTERISTICS

1. eCTD's structure

2. Granularity choices are available for every Module 1–5.

3. PDF files connected by an XML foundation.

4. More precise document searching.

5. The complete submission's transparency.

6. Navigation and review are simple.

Quality control of eCTD

a) Pre-compilation

1. Link between documents in QC.

2. Assure overall bookmarks and hyperlinks are 100% active.

3. 100% QA to ensure that overall bookmarks and hyperlinks lead to appropriate destinations.

4. Verify the existence and placement of all papers.

5. Review each document's title in the eCTD viewer.

b) Post-compilation

1. Verify eCTD.

2. Crosscheck for broken links.⁹

a). Submitting eCTD

The cover letter, both as a paper copy with any non-electronic elements and as a cover pdf (from the ICH eCTD specification, v. 3.2.2).
1. A summary of the material in the submission, consists any pertinent regulatory information.
2. A list of documents that were submitted electronically, on paper, or in both media, together with a description of each one.
3. A breakdown of the elements of electronic contribution, consisting the kinds and quantities of electronic media.
Statement that the submission is virus-free and description of tool that was implement to scan the files.
Information technology and Regulatory requirements points of the contact for submission.
Burn an eCTD master to a DVD, CD-ROM, or DLT.
After reloading eCTD from a CD, DVD, or DLT master, revalidate.
Generate eCTD replicas from the master.
The quantity of copies is decided by each EU MS.¹⁰

e-CTD ready document

Using eCTD compliant templates when developing documents will ensure that they are eCTD ready. Document reformatting consumes a sizable percentage of the "publishing time" if this is not done. The steps for producing papers that are eCTD-ready are listed below.

a). File Organization for the eCTD (Granularity)

The Common Technical Document for the Registration of Pharmaceuticals for Human Use, ICH Topic M 4, is recommended to list eCTD hierarchy levels at which document should inserted as well as whether a single document or a collection of documents is suitable at each level. The tables provide information on Modules 2 and 3 in terms of the drug substance. The storage location should not be taken into account while creating or maintaining files. When creating the dossier, the hierarchical structure will be used.

b). Specification for Submission Formats

Documents given in the different modules should generally be well prepared in accordance with guidelines in the ICH Common Technical Document. It explained how to create files that may include in eCTD.

A set of data objects that adhere to the eCTD (Electronic Common Technical Document) definition is known as an eCTD submission. The following is included in the eCTD submission:

Directory structure
XML eCTD instance
Content files

Risks involved in eCTD publishing

Regulatory offices are faced with a wide range of issues as the transition from paper-based to electronic CTD submissions proceeds globally. However, there are easy actions you can take to prevent frequent issues, which at best can raise the cost of or delay the clearance of your submission and at worst can conclude in receiving Refusal to File.

Your publication may be handled by an internal department with specific expertise that is based in the same office or on the other side of the world, or you may work with outside service providers. Your publishers may be specialized employees with administrative, IT, or creative skills, or they could be highly skilled regulatory consultants with chemical degrees. Whatever the situation, the following 10 issues frequently plague busy publishing teams. Learn what you can do to minimize or at least lessen these issues and the dangers associated with your eCTD publishing effort.¹¹

a). Source document incompatibility

b). Insufficient or conflicting information for publisher

c). Incorrect document versions

d). Short publishing timelines

e). Nonlinear delays

f). Inappropriate granularity

g). Technical problems with legacy files

h). Quality control viewing at the right point

i). Inappropriate validation process

j). Ineffective project management

REGULATORY SUBMISSION THROUGH VARIOUS ECTD SOFTWARE'S

8.1 EDUCE TM SOLUTIONS

8.2 FRYER SUBMIT PRO

8.3 PHARMA READY

8.1 EDUCE TM SOLUTIONS

A. Latest release EU-V8-1B-P2-EX2

Active directory implementation using LDAP protocol

It will be applicable for web application as well as for submission publishing (STP) and Hyperlink tools.

Web Application: When user try to login to the application, it will authenticate the user id and password from the active directory of the main domain server.

B. Super user related issue has been fixed

During new super user creation, the application will not check the super users which are marked inactive.

C. Sequence number related issue has been fixed

Practice submission indicator not allowed to be changed in higher version. in every Higher Sequence, the Practice Submission check-box will be disabled, hence the user cannot change a practice submission to regular submission or vice-versa.

D. Changes related Practice Submission indicator has been updated.

E. Inherit activity access from previous sequence related issue has been fixed

F. User activities audit screen related changes

'Export to Excel' option is provided for admin user on user activities audit screen and download CSV report option

G. Submission activities audit screen related changes

Submission activities audit screen, application will display audit report seq user can search the audit report by selecting the following filters, internal submission.

PREVIOUS RELEASES EU-V8-1B-P2

A. Tracking table

Along with MRP and DCP, now application will generate tracking table for the National as well as the Centralized procedures.
The file operation of the tracking table has been changed from ‘Replace’ to ’New’. Application will automatically upload ‘tracking-table.pdf file’ with ‘New’ operation.

B. Secured view

This feature aids you to give controlled access permissions [read / copy / print / download] of the submission(s) / module(s) / section(s) / file(s). A new interface is provided to the External Users, where the submissions to which access permissions are assigned will be available on the DASHBOARD to view submissions access wise.

C. Archive documents

D. Licensing with/without SPT features embedded in web application

E. Validation report for different activities

F. Auto removal of thumbs. dB during PUBLISH activity

G. eCTD Submission Process along with ‘PDF properties Correction as well as Verification’ | SPT embedded in Web

Compilation and Verification process will be carried out with respect to EU eCTD validation criteria. User-friendly log report is provided with set of validations as per EU Validation Criteria.

H. View – Cumulative + Sequence + Current

View menu allows user to view all the files attached in entire life cycle of submission. In Sequence View user can view or open the uploaded/attached files from submission at any time irrespective of Submission status. Cumulative View shows life cycle of all files throughout submission. In Current View only active files from all sequences are displayed

Admin Preferences

Now Admin user can control major preferences such as:

a) Fixed eCTD File Naming generation: admin can enable or disable auto eCTD file name generation logic as per ICH guidelines from this section.

b) View / Change PDF Properties: Admin can view Mandatory PDF Properties and view / change Optional PDF properties. Changes will be applicable to Web as well as client verification and correction activity.

c) Email Alerts: Admin can turn ON or OFF email alerts in Dossier-Mgmt.© system. He/ she can also set or change SMTP server settings as and when required.

8.2 FRYER SUBMIT PRO

Industry-approved eCTD software for life sciences sector is Freyr SUBMIT PRO. Biotechnology and pharmaceuticals
Freyr SUBMIT PRO, an eCTD tool, covers a variety of submission templates and formats that are needed by health authorities throughout the world. They include INDs, NDAs, ANDAs, MAAs, NDS, ANDS, DMF, ASMF, IMPD, and BLAs.
Health authorities include the US FDA, EMA, Health Canada, and Swiss Medic, among others. Freyr SUBMIT PRO, a cloud-based eCTD submission programmed, complies with all of these laws.
ASEAN, SFDA, SAHPRA/MCCZA, TGA, EAEU, JFDA, Thai FDA
Flexible integration with top eDMS
Effective and automatic validation of each user action via electronic signatures
Meticulous reporting
End-to-end submission tracking
Automated global eCTD templates
21 CFR part 11 compliant

8.2.1 Freyr SUBMIT PRO Features

Inbuilt Validator

The built-in eCTD validator is capable of detecting up to 800+ error situations and supports all regional and ICH validation requirements. It enables users to verify their contributions in accordance with the standards of different Health Authorities and their eCTD. The built-in validator of the eCTD software streamlines the submission process and boosts overall effectiveness by offering a thorough technical validation report.

Inbuilt eCTD Viewer

Freyr The eCTD submission software SUBMIT PRO enables tracking of eCTD document creation, revision, and data review up until submission. If a change in follow-up is necessary, it tells the applicants. Users of the eCTD submission software can set up notifications for the crucial submission events and examine submissions in teams. SUBMIT PRO includes a sophisticated information framework that should track the number of submissions and deadlines, removing the danger of missing submission deadlines and allowing you to quickly priorities your duties. Moreover, it provides user viewpoint monitoring and enables a thorough overview of the whole submission process.

Health Authority Query Management

Use Freyr SUBMIT PRO to track all Health Authorities' inquiries centrally for each product, and timely HA communication to guarantee quick clearance.

Integration with Leading rDMS

Freyr SUBMIT PRO was designed for flexibility and security, and it permits easy connection with current rDMS to guarantee that sensitive data is sent to the Freyr SUBMIT PRO eCTD tool in the safest possible way.

Collaborative Submissions, Preparation and Review

Establish deadlines for submissions and provide documentation that are simple to evaluate. Freyr SUBMIT PRO provides a more straightforward setting for users to work together on the same document or submission, enabling reviews and effectively fulfilling agency deadlines.

Inbuilt eCTD viewer

Use Freyr SUBMIT PRO to get rid of submission errors. The user can access submissions, research views, regulatory views, and historic submissions in a cumulative table of material.

Inbuilt PDF Manager

With Freyr SUBMIT PRO's integrated PDF manager, you can make your eCTD submissions more effective, safe, and controllable. Freyr SUBMIT PRO assists users in maintaining papers logically with features like bookmarks, internal & external linkages, and chosen access restriction settings.

Import Utility

Easily transfer any previously used dossier from other systems to Freyr SUBMIT PRO. Improve life cycle management by using Freyr SUBMIT PRO's import feature.

Module Cloning

Cloning is a feature of Freyr SUBMIT PRO, with the exception of eCTD Modules that are not region-specific (Modules 2 to 5). saving time and lowering the cost each submission.

Cross Reference Functionality

Freyr SUBMIT PRO has a cross-reference function that allows applicants to provide the physical file's path rather than copying or cloning it.

8.2.2

STEPS FOR eCTD submission with Fyer submit

**Fig 05,06,07, - Steps For eCTD submission with Fyer submit**

CONCLUSION

Both the scientist and the information systems specialist must go one step closer to comprehending each other's roles and duties in order for the switch from paper to electronic submissions to be effective. The scientist must be familiar with the science, comprehend the guidelines, comprehend the format and content of the CTD, and ensure that consistency is maintained. He must also get a little bit more familiar with XML, be aware of e-submission procedure, additionally comprehend electronic backbone. Information systems expert needs to go closer to knowing the guidelines, the Correct format and content, and effectively monitoring consistency in addition to purchasing the appropriate tools for the work, comprehending XML, and understanding the electronic backbone. Successfully navigating this change may provide your company with an advantage by saving money, improving submission accuracy, and reducing review times.

Acknowledgements:

We would like to express my special gratitude and thanks to my organization (JSS College of Pharmacy Mysore) additionally thanks to my guide Dr. Balamuralidhara V Head of the Department of Pharmaceutics JSS college of Pharmacy for giving me the opportunity of designing and write the manuscript of the review article.

Conflicts Of Interest Declaration

There are no conflicts of interest.

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Author Information

Authors:

Gaganashree T V,¹ Balamuralidhara V², Chinmayee U Gowda¹

01. Research scholar, Department of Pharmaceutics, Pharmaceutical Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education Research, Mysuru, Karnataka.

02. Head of the Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education Research, Mysuru, Karnataka

Corresponding Author:

Dr. Balamuralidhara V, Associate Professor and Head of the Department of Pharmaceutics, JSS College of Pharmacy.

Address: JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagara, Mysore – 570015 Karnataka, India.

Email: baligowda@jssuni.edu.in