Regulatory support across the product life cycle

Our team of CMC specialists is here to help you manage your product’s compliance at every step – from clinical development, to market authorization, and far beyond.

 

We help you navigate a range of critical regulatory milestones and checkpoints, including site registration, product registration, and post-approval inspections, audits, and changes.

CMC experts for regulatory support
The Vetter advantage

What sets our support apart

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Global regulatory expertise

For US and EU submissions, we can provide detailed input on CTD Module 3 (Chemistry, Manufacturing, and Controls (CMC) section) and review briefing books for your pre-submission meetings.

Streamlined process icon
Streamlined submission process

Our rigorous review process helps avoid unnecessary authority requests, incomplete filings, or time-consuming corrections.

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Single point of contact

A CMC specialist with comprehensive regulatory and technical expertise will help coordinate inputs from our subject matter experts (SMEs).

preparing CTD for key regulatory submissions
Early milestones

Supporting your clinical-phase submissions

Partner with us during your product’s development, and your team will benefit from a smooth, proven process for managing the Common Technical Document (CTD) in key initial submissions:

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

Our streamlined regulatory support process

Step 1: Kick-off

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.

Partnering on the path to market and beyond

  • Dossier preparation

    As your product progresses toward approval, we continue to provide expert support for marketing authorizations in the US and EU.

    Our Regulatory Affairs team can help you draft or review Chemistry, Manufacturing, and Controls (CMC) sections related to the processes Vetter performs for multiple key markets:

    US: New Drug Application (NDA), Biologic License Application (BLA)

    EU: Marketing Authorization Application (MAA)

  • Addressing authority requests

    If you receive a Request for Information (RfI, IR), a List of Questions (LoQ), or Deficiency Letter, we can help you deliver the accurate, conclusive response you need to smooth the approval process.

    We handle requests like these on a regular basis, giving our team a continually evolving, up-to-the-minute view of authorities’ interests, priorities, and focus areas.

  • Post-approval support

    Once your product is on-market, we can further assist you with any variations you need to file related to major post-approval CMC changes (PAS, Type II), including reviews of your Post-Approval Change Management Protocol (PACMP).

  • Supporting submissions in Japan (PMDA) and South Korea (MFDS)
    Global regulatory submissions 

    Thinking ahead to future markets? We’re here to supply the declarations or additional documentation you need to support submissions to authorities around the world.

    Our team has successfully navigated many unique approval and registration pathways, including authorities in Asia with highly specific requirements:

    Paper-based inspections: We have extensive experience with the inspection process mandated by South Korea’s Ministry of Food and Drug Safety (MFDS) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

    Foreign Manufacturing Accreditation (FMA): All our sites in Germany have received this certification, which is required by Japan’s regulatory authorities. FMA documentation can be provided to you on request.

Track record as a CDMO
Demonstrated expertise

Our proven record of regulatory success

Throughout our 40+ year history as a global CDMO, we have established a solid success record with regulatory agencies worldwide – including in the US, EU, and Japan. We currently manufacture over 105 products approved by the FDA and EMA alone.

Throughout the year, our facilities also undergo regular inspections by national and internal authorities. Over the past decade, we’ve been successfully inspected by nearly every regulatory body around the globe, including both routine cGMP and pre-approval inspections (on-site and paper-based).

Learn more

Facts & figures
110 +
FDA- and EMA- approved products currently being manufactured at our facilities
10
successful facility inspections by international regulators in 2022
71
customer audits in 2022
  • Wolfgang Weikmann, SVP Quality

    At Vetter, we always strive to continuously optimize our systems and processes to enable consistently high-quality manufacturing of our customer’s drug products and compliance with international regulations like the US Code of Federal Regulations (CFR) and the EU GMP Annex 1.

    Wolfgang Weikmann, Senior Vice President Quality

    Read the Annex 1 interview

  • Our Regulatory Affairs team has broad knowledge and experience in CMC, cGMPs and Quality matters, enabling regulatory compliance and smooth submissions across your injectable product’s life cycle.

    Katja Kotter, VP Regulatory Affairs/Quality Compliance

Contact person at Vetter

Connect with us

Interested in our services? Reach out to our team of experts to discuss how we can support you and your injectable product.

Get in touch