Regulatory support for your clinical trials

Our experts provide the guidance, insight, and Vetter process documentation you need to prepare a Common Technical Document (CTD) for clinical trials of your injectable drug product.

CMC team meets to discuss clinical-phase project

Quality and compliance from the first step

Efficiently and successfully navigating regulatory pathways is a critical step in keeping your clinical development cycle on time and on budget. In addition laying strong regulatory groundwork during your clinical trials can set your product up for even greater success at key future milestones in your product’s life cycle.

Our Regulatory Affairs team is here to provide the regulatory support to keep your product’s timelines on track – from your first clinical batches, to Phase 3 and beyond.

What comes with our support

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Global regulatory expertise

With our vast experience, we know regulatory authorities’ specific requirements and expectations for CTD Module 3 (Chemistry, Manufacturing and Controls (CMC) part) in markets like the US and EU. We also support you by reviewing packages for pre-submission meetings (briefing books).

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Streamlined submission process

Our high-quality review process helps avoiding unnecessary authority requests, incomplete filings, or time-consuming corrections.

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Single point of contact

Your Vetter CMC expert has comprehensive regulatory as well as technical knowledge and coordinates the input of the Vetter subject matter experts (SME).

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Advancing your clinical-phase regulatory projects

Take early advantage of our expertise, and your team will benefit from a smooth and proven process for managing your Common Technical Document (CTD) for clinical submissions, such as: 

  • Investigational New Drug Application (IND)
  • Investigational Medicinal Product Dossier (IMPD)

Our streamlined regulatory support process

Step 1: Kickoff

We start our partnership with a clear, detailed understanding of your needs and goals. With this, we can identify the best approach to compile the Vetter process information needed for your dossier (CTD), establish detailed timelines, and drive efficiency from the beginning.

Step 2: Document prep

After kickoff, our CMC experts support you in reviewing and/or writing of the files for your IND or IMPD in compliance with the relevant regulations. Wherever possible, we streamline your submission by using established text modules that have been proven to be accepted by the relevant authorities. We also support Drug Master files (DMF) on Vetter-specific primary packaging materials.

Step 3: Document review

Your filing is examined by all relevant departments at Vetter, then consolidated in a draft of the relevant dossier chapters (Module 3) by our CMC experts. After completing our internal review, our CMC expert will provide you with the consolidated CMC information needed for your submissions. Collaborative review by your SMEs and Regulatory Affairs experts and our CMC expert leads to a submission that precisely maps our processes to your specific requirements.

Step 4: Responding to authority requests

If an authority makes any additional information requests related to your IND or IMPD, our CMC team supports you with our comprehensive experience.

Our Regulatory Affairs team has broad knowledge and experience in CMC, cGMPs and Quality matters enabling regulatory compliance and smooth submission of your clinical trial application.

Katja Kotter, VP Regulatory Affairs/Quality Compliance

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Continuing support beyond your clinical submission

Learn how our Regulatory Affairs experts can support you and your products not only for your clinical trials but also for marketing authorization and beyond – with applications to global regulators, post-approval changes, and more.

Learn more

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Learn more about our services

Reach out to our expert team to discuss how we can support you. 

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