Advance your biopharma asset
Thermo Fisher Scientific is your preferred deal enablement partner for
integrated CDMO, CRO, and clinical supply solutions
Turn your biopharma asset’s potential into performance
In today’s drug development landscape, partnering with a trusted CDMO and CRO is essential to manage and maximize the value of your assets. At Thermo Fisher Scientific, we deliver industry-leading pharma services backed by a global network of scientific, technical, regulatory, and quality experts.
Our proven regulatory expertise, rigorous quality assurance, and dependable clinical supply solutions turn potential into performance—helping patients worldwide.
Whether you have recently acquired a new biopharma asset or are planning to, our comprehensive capabilities can provide support at every stage.
With unmatched expertise and an unwavering commitment to excellence, we ensure your development and commercialization goals are achieved seamlessly. Partner with us to navigate regulatory complexities, ensure GMP compliance, and position your scientific innovations for global success.
Quality you can count on
Trust in our impeccable regulatory track record, global GMP oversight, and robust quality systems. We get it right the first time—empowering you to achieve your business objectives
with peace of mind.
Proven regulatory excellence
Navigate complex regulatory landscapes with confidence
With deep expertise and global reach, we ensure compliance and smooth market entry, minimizing risks and delays. Partner with us for regulatory support and quality assurance that keeps your project on track and inspection-ready.
- Global regulatory expertise: Leverage the combined regulatory knowledge of our global network, covering the entire drug lifecycle for various product types.
- Comprehensive support: Benefit from our regulatory submission strategies, agency meeting support, registration file gap analysis, and CMC dossier preparation.
- Integrated services: Experience seamless coordination with our subject matter experts for direct project assistance and timely deliverables, all under one roof.
620 dossiers across
241 products
From 2020–2024, we provided regulatory support on 620 dossiers (writing and review) related to
241 products.
- New dossiers in 2024: 122 (EU) and 21 (NA)
- New products in 2024: 35 (EU) and 21 (NA)
Undergo ~60–70
inspections annually
Ample experience with regulatory agencies across the globe, including the FDA, EMA, and NMPA.
235 marketing
application approvals
Helped customers obtain 235 marketing application approvals (NDA, BLA, and MAA) from 2018–2023.
128 regulatory approvals
Supported 128 regulatory approvals (NDAs/BLAs) over the past five years (2019–2023).
Reliable supply, globally: Wherever you are, we are
When your success depends on producing products for patients around the world, you need a partner with reach—across the US and the globe.
Our integrated logistics, assured supply continuity, and scalable engagement models enable you to navigate global markets with confidence and ease.
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Asia Pacific (APAC)
Latin America (LatAm)
North America (AMER)
Florence, South Carolina (East), USA
Capabilities:
Florence, South Carolina (West), USA
Capabilities:
Europe Middle East Africa (EMEA)
Expert tech transfer services
We offer reliable, streamlined technology transfer services to ensure a smooth transition from development to commercial production.
Our capabilities include:
- Comprehensive support: From route scouting and process development to analytical methods and regulatory support, our integrated services guarantee a seamless experience.
- Expert coordination: Our industry-leading subject matter experts provide hands-on support, ensuring the timely and efficient execution of your tech transfer—all under one roof.
See how harmonized processes and standardized systems maintain product integrity throughout technology transfer:
How to ensure reliable and simple tech transfer.
Our extensive pharmaceutical development services (PDS) provide robust support throughout the entire drug lifecycle
Small molecule PDS
- 50+ years of CGMP API manufacturing experience
- In 2024, we managed 386 active development OSD projects, including 152 early-phase and 234 late-phase molecules
- In 2024, there were 250+ active OSD technology transfer projects within the Thermo Fisher site network
- Thermo Fisher provided CDMO services for 135 NDAs that received FDA approval in the USA between 2011 and 2024
Oral solid dose capabilities
- Formulation development
- Solubility enhancement
- Complex formulations
- Process development
- Analytical methods development
- Regulatory support
- Clinical packaging, labeling, and TTM
- Commercial packaging
API capabilities
- Route scouting
- Solid state/physical characterization
- Polymorph and salt screening
- Process development
- Complex API development
- Scale-up process development/cost optimization
- HiPo API development
Large molecule PDS
- 30+ years of clinical and commercial manufacturing experience
- 840+ biologics batches manufactured globally (2018–2024)
- Over 150 million sterile liquid and lyophilized vials produced in 2024
Biologics capabilities
- Cell line development
- Process development
- Analytical method development
- Process transfer
Steriles capabilities
- Lyophilization optimization
- Phase-appropriate method validation
- Stability studies
- Clinical batch production
- Clinical assembly and packaging
- Commercial assembly and packaging
Explore how our innovative 360° CDMO and CRO services support your aspiration to get treatments to patients faster
Our unified framework seamlessly bridges early development and late-stage execution—speeding up your path to licensing and commercialization, globally.