Gap Analysis and Authoring

Overview

Thorough Regulatory assessment/gap analysis of the source documents/data and the first time right quality authoring of CTD sections for an ANDA application are very vital to clear the RTR screening and also receive the approval in the first review cycle on goal date, which allows the manufacturer/ANDA holder to market the generic drug in the USA region without delay.

Gap analysis of all source documents/data/study reports helps in identifying the gaps in the ANDA content and can allow to build the mitigation plan and strategy to provide logical and scientific justifications to avoid major queries from the USFDA subsequently to receive approval on time.

Freyr, with a highly skilled cross-functional team and expertise in Regulatory submissions, can assist applicants to determine the HA requirements and perform comprehensive ANDA gap analysis and authoring of source documents/data.

Freyr Expertise

01
Regulatory Assessment/Gap analysis of the source documents/data for adequacy as per the USFDA requirements
02
Sharing of identified gaps Providing the necessary mitigation strategy for identified gaps
03
Experienced resources with previous experience in R&D, quality and analytical departments for an in-depth review of the documents/data
04
Review of the documents/data/reports for their compliance with Refuse-To-Receive (RTR) standards
05
Implementation of best practices/guidance/queries with previous submission to the USFDA in ANDA gap analysis and authoring
06
Authoring of CTD sections using the CTD templates as per the USFDA’s ANDA requirements for content and format
07
Authoring of CTD sections for supplements/amendments/annual reports to the registered applications as per the USFDA expectations
08
Assessment of the Regulatory submission strategy
09
Review of the qualitative and quantitative composition of the medicinal product for acceptability
10
Impurities limits as per the ICH requirements based on MDD
11
Gap analysis of the protocols/reports for product development, process validation, stability program, exhibit batches, batch size for registration, hold time study
12
Dissolution method/parameters selection
13
Biowaiver criteria
14
Health Authority mandatory requirements
15
Gap analysis of draft CTD package to ensure the adequacy for submissions like ANDAs/DMFs
16
Gap analysis of the supplement submission strategy and suggestions

What our Clients Say?

It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.

President

An Innovative Pharmaceutical Company

This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided. This project is not yet complete but has been very successful at this point.

Quality Control and Regulatory Manager

USA-based Pharmaceutical company

The ANDA receipt is received! Thank you very much for your hard work, patience and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. Thank you again and look forward to working with your team on the next project!

Research and Technology based US pharmaceutical company

Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.

Senior Research Assistant,

US based leading biopharmaceutical company

We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and how we operate, it is possible to realize our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team.

Operations Head,

A Privately Held Pharmaceutical Research and Development Company

Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.

System Owner,

UK multinational pharmaceutical company

Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating, regarding the QA database etc.

Graphics Manager | Global Regulatory Affairs,

Canada based, global pharmaceutical company

Gap Analysis and Authoring

Overview

Freyr Expertise

Regionwide Expertise

What our Clients Say?

President

Quality Control and Regulatory Manager

Senior Research Assistant,

Operations Head,

System Owner,

Graphics Manager | Global Regulatory Affairs,

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Gap Analysis and Authoring

Overview

Freyr Expertise

Related Services

Regionwide Expertise

What our Clients Say?

President

Quality Control and Regulatory Manager

Senior Research Assistant,

Operations Head,

System Owner,

Graphics Manager | Global Regulatory Affairs,

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Get in Touch

USA

UK

GERMANY

INDIA

More Locations

Quick Inquiry