Integrated drug development and clinical services

Solving your challenges faster with one connected, accessible team

Our global subject matter experts operate as an integrated, accessible team to solve your challenges faster. From drug substance, drug product, and clinical trial manufacturing to clinical supply optimization, we combine proven end-to-end capabilities and state-of-the-art technologies with dedicated team members across business units who share your mission to help patients and improve healthcare. Using the strength of our global network, we’re working to simplify and accelerate the development process to get you to clinic—and to market—sooner.

14 weeks; $44 million

Patheon™ Quick to Care™ clients save an average of 14 weeks on drug development timelines to net $44 million

13 months

From transfection to IND in as little as 13 months for biologics, saving you money and time

14 months

From API to clinic in 14 weeks—one month faster than the standard timeline

14 weeks; $44 million

Patheon™ Quick to Care™ clients save an average of 14 weeks on drug development timelines to net $44 million

13 months

From transfection to IND in as little as 13 months for biologics, saving you money and time

14 months

From API to clinic in 14 weeks—one month faster than the standard timeline


Integrated solutions and capabilities 

Our Patheon™ Quick to Care™ program is designed to streamline your drug substance and drug product development, demand planning, and clinical trial supply execution into a single customized solution. We help you simplify your supply chain and accelerate development with a seamless, one-team approach. Coordinating multiple vendors takes valuable time and resources—this single-vendor solution offers benefits across the continuum, including:

  • Dedicated project management: An experienced, dedicated program manager pulls our integrated capabilities together into a single solution for you, creating and managing the governance process and drawing on technical experts from across our network. This single point of contact helps deliver coordination, communication, commitment, and accountability across the entire supply chain.
  • Tailored solutions just for you: Whether your goal is out-licensing at Phase IIb or taking your molecule to full commercialization, it requires a dedicated, trusted, and experienced partner that understands your complex needs. Our team of global experts provides unified program management and scientific and technical insight while curbing redundancies to ensure success in your drug development journey.  

One shared commitment: Your drug development success 

How do we do it? 

Integrate only the services needed for your drug development and clinical services solutions 

Solve technical challenges quickly with access to scientists and technicians worldwide 

Streamline development, manufacturing, and logistics through a global network of 60+ sites 

Scale drug substances, drug product, clinical supply, and transportation management 

Launch and deliver new treatments to patients without time-consuming tech transfer delays 

Now more than ever, you’re asked to do more in less time. Patheon™ Quick to Clinic™ is our speed-focused solution, built for small and large molecule drug development as well as viral vector services. It’s designed to accelerate early development while using a proven process platform, ensuring that critical details aren’t overlooked.

  • PatheonTM Quick to ClinicTM solution for biologics: Go from transfection to IND in as little as 13 months, using a carefully constructed program with a tried and tested process platform supported by a high-yield and royalty-free expression system, and supply assurance to mitigate raw material sourcing risks. All designed to balance speed and risk, preparing you for long-term commercialization success.
  • PatheonTM Quick to ClinicTM solution for small molecule: In as little as 14 weeks from receiving your active pharmaceutical ingredient (API), you can have your Phase I product manufactured, labeled, packaged, and delivered to the clinic. That’s up to one month faster than most standard timelines.
  • PatheonTM Quick to ClinicTM solution for viral vector services:
    An integrated development program using optimized, IND-ready platform processes for Lentivirus and adeno-associated virus (AAV) manufacturing with scalability up to 200 L. 

Helpful resources 

Partnering with small pharma and emerging biopharma
We work on an average of 27 new biologic programs per year, with 63% of those projects for monoclonal antibodies.  

As an industry-leading partner with a proven track record, we have received as many New Drug Application (NDA) approvals as the next three CDMOs combined over the past 10 years.

For a successful submission, strong regulatory expertise—including deep knowledge of constantly evolving International Council for Harmonisation (ICH), European Medicines Agency (EMA), and Food and Drug Administration (FDA) guidelines—is non-negotiable. Our regulatory affairs team provides unparalleled support for clients during development/pre-approval and post-approval for dossier maintenance. Our experience with regulatory bodies worldwide and close collaboration with your drug development team means we can help you get to market quickly.

We deliver professional experience in regulatory affairs and procedures, beginning with independent and trustworthy advice on the best regulatory strategy. We can guide you through every step of development, including clinical studies—for example, selection of reference product and preparation of Investigational New Drug Application (IND), Investigational Medicinal Product Dossier (IMPD), and clinical trial applications. 

 

Through our clinical services offering, we provide reliable clinical trial labelling, packaging, and distribution. We’re also here to help with your final milestones, including regulatory dossier compilation—writing and collecting all documentation needed for the submission. We are skilled in submitting your applications to regulatory authorities; monitoring and responding to regulatory queries; and formally closing out application procedures.

Our support does not end at drug approval. We offer a post-approval compliance review of dossiers based on changing global legislation. Additionally, our team can provide maintenance throughout the full dossier lifecycle, including variations and renewal applications.

Helpful resources 


Benefits of partnering with us

With our breadth of experience, scientific expertise, and globally integrated network, we provide you with a customizable solution to reduce your development timeline. We apply a science-driven, risk-based approach to every step of the development and manufacturing process, while providing you with a global footprint and the scientific and therapeutic expertise to ensure your discovery makes it to the patients who need it most. We have one shared commitment—your drug development success.