At PeploBio, we offer comprehensive regulatory affairs services to help medical device manufacturers obtain FDA approval for their devices. Our experienced team of experts specialiszes in clinical, regulatory, and quality affairs, providing a complete range of services to ensure your device meets all necessary requirements for market approval.
We provide a complete range of regulatory affairs services to support your medical device throughout the regulatory process.
Comprehensive regulatory affairs services: Our experts specialise in clinical, regulatory, and quality affairs, providing a complete range of services to ensure your device meets all necessary requirements for market approval.
Customised regulatory strategies: We work with you to develop a customised regulatory strategy that addresses your specific device and business needs.
FDA expertise: Our experts have extensive knowledge of FDA regulations and guidance documents, ensuring that your device meets all necessary requirements.
Proven track record: We have a proven track record of success in obtaining FDA approval for medical devices across a wide range of therapeutic areas.
PeploBio is a UKAS accredited Medical Laboratory No. 22998. Our UKAS accredited ISO:15189 laboratory has robust quality processes in place, essential for supporting drug and vaccine discovery, validation, and development.
We are ICO registered organisation with clearly defined data privacy policies, and robust data protection systems to ensure third party patient data remains protected.