Build or augment your Quality Assurance team with top talent or outsource projects to an expert third party. We help thousands of life science companies find specialized resources and drive their projects to completion on-time and on-budget.
Develop and submit applications alongside former FDA and industry experts or fill in-house roles with select talent.
Maximize cost-effectiveness, flexibility, and scalability when building a partial or full in-house clinical operations team through rapid, reliable access to experienced clinical experts.
Need third-party project or resourcing assistance to support commissioning, qualification, and/or validation activities? We can provide the expertise and capability you need no matter which role you need to fill or which phase your project is in.
Need expert help navigating regulatory, scientific, and technical challenges to ensure compliance, bolster your production capability, and guarantee timely delivery? We help you achieve your next milestone by offering our expertise in all aspects of CMC development, including product, process and test method development, product stability testing, phase-appropriate validation, packaging development, and manufacturing and testing under GMP conditions.
Our consultants, many of whom are former FDA, are experts in the science and activities related to detecting, evaluating, understanding, and preventing adverse effects associated with pharmaceutical and medical device products. Teams work with us when they want to ensure the safety of their products throughout their lifecycle.
The FDA Group provides life science companies access to highly skilled medical writing consultants who can handle a wide range of medical writing projects and needs. Our consultants are experts in creating clear, precise, and compliant documents essential for regulatory submissions, clinical trials, and scientific communications. Teams work with us when they need expertly crafted documentation that meets the highest standards and regulatory requirements.
Interpreting and acting on FDA regulations can be difficult and complex. We connect you to former FDA officials and public health officials who regularly serve as knowledgeable expert witnesses.