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