Why outsource

Why should you outsource to BioTechnology Transfer?

You will benefit from our:

  • Extensive experience in working with the FDA and EU notified bodies in getting premarket approvals/product clearance
  • Experience in transfer of a wide variety of technologies from research to market
  • Training as research scientists and engineers
  • Practical expertise in design control and realistic application of quality assurance systems
  • Knowledge of world-wide regulatory requirements
  • Easily updated systems that are designed to grow with your business and to meet changing QA/RA requirements

Save time and money:

  • Build an efficient business with fewer employees
  • Pay only for services you need; once systems are in place they are easily administered by trained, but less costly, personnel
  • Keep your critical projects on track by keeping your scientists and engineers focused on development
  • Reduce costly mistakes

Early implementation of our systems into your company structure will:

  • Get your labs, QA/RA, and manufacturing systems up and running quickly to the latest regulatory standards with our scalable manuals and procedures
  • Increase critical employee efficiency – scientific staff are free to focus on what they do best – designing and developing products
  • Allow capture and efficient transfer of R&D knowledge to quality, regulatory, manufacturing, and technical support personnel
  • Speed product development and agency clearance to market
  • Streamline audits by FDA and ISO 13485 accreditation bodies
  • Simplify company-wide compliance to world-wide regulatory requirements