RegWeb Consulting Services
Case Studies
Case Study 1: Registration of New Drug in Emerging Markets
Challenge
Client needed support to register a new product already approved in Europe in Emerging Markets.
Our Approach
- Direct engagement with client country affiliates and our regional experts to discuss filing requirements, submission components and requirements, data availability, and risks.
- Development of regulatory strategy documents to facilitate decision-making by the client and manage regulatory risk.
- Authoring of Module 1, 2.3, and 3 per country requirements.
Benefits and Outcomes
- Multiple emerging market submissions with several approvals, with limited regulatory questions in key markets.
- Close engagement and open dialogue with client regulatory teams and country affiliates.
- Our regulatory expertise and knowledge are recognized and appreciated by the client.
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Case Study 2: Support to Develop Regulatory/CMC Intelligence Database
Challenge
The client needed support to develop a regulatory/CMC intelligence database for requirements of clinical trial applications and marketing authorization applications.
Our Approach
Content development is based on:
- Regulations/guidance documents.
- Input from the local network.
- Past experience.
Benefits and Outcomes
- Development of database within the agreed timelines.
- Our regulatory and CMC expertise is recognized and appreciated by the client.
- Weekly maintenance of the content to keep the database up-to-date.
Case Study 3: Submission of USDMF for an Investigational Vaccine containing Adenovirus Group C Vector
Challenge
An EU-based client (manufacturer) needed support in authoring and submission of CMC information, for an investigational vaccine containing adenovirus group C vector, to USFDA without disclosing the information to sponsor of the clinical trial (IND applicant).
Our Approach
- A robust submission strategy was made through which a single USDMF both for DS and DP was submitted to CBER and a letter of access was provided to the IND applicant to access the DMF for CMC information.
- Modules 1, 2, and 3 were authored and submitted.
- Current FDA guidelines were considered while authoring Module 3.
Outcomes
- Submission was successfully made to CBER.
- USDMF was reviewed during the assessment of IND and no questions were asked by CBER.
- Clinical trials are ongoing.
- Successful ongoing collaboration with the client with the annual report being submitted every year.
Case Study 4: Module 3 authoring for an MAA of a gene therapy product
Challenge
An EU-based client needed support to author Module 3 for an MAA of a gene therapy medicinal product comprised of ex-vivo genetically modified cells.
Our Approach
- Gap analysis of Ph 3 IMPD was performed.
- Additional information needed for Module 3 of an MAA was identified and requested.
- Module 3 was authored considering current EMA guidelines on gene therapy products.
Outcomes
- Successful submission of application and approval of the product by EMA last year.
- Our CMC support was recognized and appreciated by the client.
Case Study 5: Module 3 authoring for an MAA of a gene therapy product
Challenge
A US-based client needed support to author sections of Module 3 for an MAA of a gene therapy medicinal product containing a modified adeno-associated viral vector.
Our Approach
- Source documents were identified and requested.
- Sections of Module 3 were authored and updated per client’s review comments.
Outcomes
- Successful submission of application to EMA.
- Assessment of the application by EMA is in progress.
- Provided support to the author’s responses to the questions.
- Authoring of BLA for submission to the US FDA is ongoing.
Case Study 6: Post approval quality variations for a gene therapy product
Challenge
An EU-based client needed support to prepare the regulatory strategy and author CMC sections for variations of ex-vivo stem cell gene therapy products. The variation applications were previously rejected by EMA due to the wrong selection of the variation category.
Our Approach
- Regulatory assessment of the changes was performed.
- A correct variation category was proposed and accordingly supporting documents were requested.
- Justification and rationale of the changes were authored along with amended Module 3 sections.
Outcomes
- Type II variations were successfully submitted and approved by EMA without any questions.
- Our Regulatory and CMC support was recognized and appreciated by the client.
What our clients say
Our clients are the best testament to our acumen and capability.
“We have had the pleasure of working with our partners at RegWeb for several years across many clients and regions. The team are extremely detail orientated and organised when preparing their excellent written documents for regulatory submissions. Additionally, the team are very personable and integrate into projects seamlessly, they are our trusted partners in North America and we continue to build a Rapport year on year!”
Ifty Saiyed
“We from Clarivate Cortellis CMC intelligence team glad to provide this testimony to the work done by RegWeb team on providing the professional services to develop and further maintain the CMC Intelligence database. RegWeb consulting team have always done their best to meet the exact requirements of the CMC project and helped us to achieve the internal milestones to publish the content for Biologics development for identified Regulatory entities across the globe. And now we are pleased to extend their services for Small molecules maintenance as well.”
