Global regulatory services and support

Unmatched regulatory partner for end-to-end drug Chemistry, Manufacturing & Controls (CMC) strategies and deliverables

Thermo Fisher Scientific’s pharma services offering has an integrated global network of manufacturing sites that includes regulatory, technical, quality, Qualified Person (QP), and customer engagement teams that can support and solve complex challenges at every stage of your molecule’s lifecycle.

From 2013 to 2022, Thermo Fisher Scientific received more NDA/BLA approvals than the next two leading CMOs combined. Our proven track record and unparalleled expertise empowers the industry’s top biopharma companies to feel confident partnering with us.

Our strong and diverse regulatory expertise, based on solid knowledge of the requirements of major entities (ICH/EMA/FDA) and a commitment to staying abreast of new regulatory trends, is the foundation that enables us to deliver exceptional services continuously recognized by our customers.

Regulatory affairs expertise

Our regulatory affairs function provides industry-leading guidance to customers regarding the chemical and biological molecules we help develop and manufacture, spanning the product lifecycle from development through clinical and commercial. To date, we have supported regulatory submissions in approximately 150 countries.

Delivering professional support regarding regulatory affairs requirements and procedures, including:

  • Independent and trustworthy advice on the best regulatory strategy
  • Guidance through every step of the drug lifecycle, including:
    • Clinical applications. For example, preparation of Investigational New Drug (IND) applications and Investigational Medicinal Product Dossiers (IMPD)
    • Pre-market applications. For example, preparation of Biological License Applications (BLA) and Marketing Authorization Applications (MAA)
    • Post-market applications. For example, preparation of Post-Approval Supplements (PAS) and variations

Navigating a complex regulatory environment is vital to the success of your molecule’s lifecycle. Our industry-leading experience with regulatory bodies worldwide and close collaboration with your drug development, scale-up, and technology transfer teams empowers us to help get your medicine to market faster.

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