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Regulatory Services

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Eurofins CDMO (Contract Development & Manufacturing Organization) operates in the regulated environment and has the capability to support a broad range of development stages.  At Eurofins CDMO, we are committed to provide our clients with our regulatory expertise and international experience all along the product development, from early stage of API development up to pre-clinical program and clinical supplies.

We have the capability to assess your project from a regulatory perspective, provide technical advice on your development program, including batch manufacturing, and prepare the regulatory documents in compliance with the latest international standards in the perspective of clinical trial application and product registration. Whatever the stage of your product development, a skilled team of experts will be able to answer your question and provide the best advice.

Regulatory support is available across the spectrum of CDMO activities and targets the preparation of your product for the market with the correct level of control, supportive information and Quality & Regulatory oversight.

The scope of Eurofins CDMO Regulatory Services covers IND/IMPD and NDA/CTD enabling activities through:

  • Evaluation of and advice to development programs related to chemical, manufacturing and control aspects considering development stage and intended use of the product,
  • Technical and regulatory assistance for the definition of specifications and stability protocol,
  • Regulatory review of technical reports,
  • Preparation of Active Substance Master File (ASMF/DMF),
  • Preparation of compliant regulatory documents for clinical trial application (IND/IMPD) and international registration (NDA/ANDA/BLA/CTD/NTA)
  • Expertise and Quality Overall Summaries
  • Responses to Questions
  • Life Cycle Submissions (amendments, variations…)
  • Consultancy
  • Regulatory services are conducted in compliance with the international environment (ICH, EMA, FDA, USP/PE, etc.)

 

Choose Eurofins CDMO to help you:

✔ Ensure a consistent and consolidated approach across technical and regulatory aspects through interconnected teams
Establish and execute phase-appropriate clinical trial and commercial phase-enabling manufacturing processes & controls for Drug Substance and Drug Product
✔Develop appropriate, end-to-end control strategies, focusing on control of product identity, safety, potency and variability
✔Gain high-level regulatory support throughout your pharmaceutical and preclinical program
✔Draft, review and compile the Chemistry, Manufacturing & Control (CMC) dossiers, to regional expectations

 

Regulatory Services
IND /IMPD Services NDA/CTD Services