Product development services for medicinal products

Product development services for human and veterinary medicinal products

Medfiles provides comprehensive product development services for human and veterinary medicinal products – from early clinical phases to marketing authorisation. Our competent development team creates a flexible and cost-efficient development strategy for your product, according to your needs. We are ready to help our clients in product development around the world.

We have more than 25 years of experience in pharmaceutical product development. By selecting Medfiles as your partner, you can be sure that your medicinal product meets the requirements set for its manufacture and quality control.

Our project managers ensure that your project proceeds according to the set product development programme:

  • Physical and chemical characterisation of the active pharmaceutical ingredient (API) and reference listed drug (RLD) 
  • Formulation development according to the QbD principles:
    • Essential characteristics of the drug product under development and the quality target product profile (QTTP)
    • Selection and sourcing of excipients and primary packaging materials
    • API/excipient compatibility studies
    • Identification of critical quality attributes (CQA)
    • Identification of critical process parameters (CPP) which may have influence on the CQA
    • Process development and optimisation
  • Analytical method development
  • Technology transfers, scale-up and comprehensive documentation during the industrialisation phase with the help of our experienced experts
  • Stability study services

Our product development services cover the following dosage forms:

  • Tablets
  • Hard gelatin capsules
  • Liquids
  • Suspensions
  • Semisolid formulations

Free guide: determining storage conditions for pharmaceuticals

The storage conditions for medicinal products should be based on an evaluation of the stability studies undertaken on the finished product. We have created a guide on what you need to know about determining storage conditions for pharmaceuticals, so that you can make the best choices for your project.

Clients

Our team serves businesses in the pharmaceutical sector around the world. Client satisfaction and trust are of paramount importance to us.

Cooperation with Medfiles has been great. The response times are quick, and the staff is always ready to help. Our requests are always met – even within tight schedules – which we highly appreciate.
– A Finnish pharmaceutical manufacturer

Contact us