Regulatory and Validation & Verification

Gsap provides extensive regulatory support from regulatory strategy development and submission to surveillance audits and liaison with FDA, Notified Bodies and other Competent Authorities.

We work thoroughly and vigorously, incorporating a balanced business approach, to bring the most suitable and high quality resolutions for our clients.

These services include:

A. Regulatory strategy.

B. Consultation with regulatory authorities (FDA, Notified Bodies, Competent Authorities).

C. Planning, Writing and Review of Submissions:
(FDA 510(k), PMA, Technical File for CE mark, Health Canada, AMAR and east Asia).

D. Product-related Regulatory Support and Technical Guidance for the R&D process including the implementation of suitable Standards and Testing, Product Verification and Validation activities, etc.

E. Pre-clinical and clinical services, such as clinical evaluation Investigator Brochures, Informed Consents etc.

F. Periodical Standards Review to include every new standard relevant to the client’s device.

At its heart, engineering is about using science to find creative, practical solutions. It’s a noble profession.
Queen Elizabeth II