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.
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.
Helpful Resources
Fact Sheet
Global regulatory services backed by industry experts
Navigating a complex regulatory environment is vital to the success of your product’s lifecycle. Thermo Fisher Scientific provides a range of flexible regulatory solutions that can help easily address your molecule’s unique needs and challenges, while being backed by a global network and seasoned regulatory experts.
View Fact Sheet
Brochure
Developing a CMC and regulatory roadmap for your molecule’s lifecycle
Getting your strategy right from the start of your molecule’s journey can help save time and money as you advance through each phase and proceed to commercialization.
Webinar
Building a robust FIH biologics regulatory CMC package
When you enter the clinical trial stage of your molecule’s development, you must prepare a dossier to support conducting the clinical research.
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Webinar
Navigating the EU regulatory landscape: Accelerating drug development, treatment innovation and market access
During this three-part webinar series, we cover key areas sponsors must be mindful of during drug development in preparation for filing successful regulators submissions.
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Whitepaper
European regulatory landscape: Demystifying new Qualified Person (QP) requirements for supplying medicine in the EU and UK
To ensure full compliance and timely and efficient batch release processes, drug sponsors pursuing clinical trials and commercialization in the EU and UK require a deep understanding of European...
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Infographic
Regulatory pathways for CGT and ATMP products
CGT is one of the world's fastest-growing therapeutic areas today. Instead of treating patients for the rest of their lives, these therapies offer them hope of a cure. In this infographic, we will review three tips for achieving regulatory success.
Fact Sheet
Qualified Person (QP) Services
Learn how our team of QPs bring extensive experience across a wide range of dosage forms including aerosols, biologicals, creams, liquids, ointments, solids, sterile products and novel drug delivery systems.
Article
Streamlining small molecule API development and regulatory compliance
The end goal of API innovators is to develop an API that will succeed in clinical trials. Many steps and processes are considered in formulation and development that would enable an API to successfully transition to the clinic.