Our expertise
Eurofins CDMO is 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 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.
Eurofins CDMO facilities, based in Mississauga, Canada, have successfully been inspected and approved by international regulatory agencies such as the USFDA (2008-2011-2014-2016-2019) and Health Canada (2014-2016-2017-2019-2022-2023). The experienced quality team works with our clients to meet their phase appropriate quality and regulatory needs and is able to assist them with their regulatory filing; whether for preparation or review of CMC or DMF filings.
IND/IMPD Services
Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies offers the skills and capability to prepare and review documents for clinical trial application (IND/IMPD).
This includes:
- Manufacture and support for Phase I, Phase II and Phase III studies
- IND / IMPD quality sections related to drug substance and drug product: manufacturing, control, stability, description of clinical supplies, including placebo and comparators
- Responses to Questions during assessment procedure
NDA/CTD Services
Regulatory experts from Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies draft, review and manage the necessary documents to enable the building of Common Technical Document (CTD) for product registration and life-cycle submissions.
This includes:
- CTD module 3 and Quality Overall Summary in compliance with international standard (ICH guidelines, EU-EMA, USFDA, Health Canada, TGA, Asean guidelines)
- NTA part 2 and corresponding Expert report for Veterinary medicinal products.
- Advice on registration strategies during product life cycle.
- Variations and amendments to existing Marketing Authorization.
- Responses to Questions during assessment procedure.
Talk to our CDMO experts