Exponent has successful experience with the regulatory agency interactions and communication with healthcare professionals for product submissions, clinical and technical development plans, Chemistry, Manufacturing and Controls (CMC) and post-marketing issues. We can assist clients deal with regulatory non-conformity matters as outlined in 483 and FDA warning letters, as well as product recall situations. Our services in regulatory affairs will include:
- Devise regulatory strategies for development of drugs, biologics and medical devices for successful products registration in the US and internationally by working along side with your regulatory team including defining pre-clinical, non-clinical, clinical and manufacturing steps
- Write, compile and produce regulatory registration submissions including INDs, ANDAs, NDAs
- Create electronic regulatory submissions that conform to FDA and ICH guidances.
- Support the development of the CMC section of regulatory submissions
- Coordinate, attendance and participate in formal and informal FDA meetings to formulate or clarify product development strategies
- Prepare comprehensive pre-meeting submission packages
- Manage product recalls and prepare responses to 483s and FDA Warning Letters
- Analyze adverse event reports, identify specifics products or lots to be recalled
- Implement Corrective and Preventive Action (CAPA) plans, including root-cause analysis
We also assist our clients in quality systems implementations and improvements for compliance with Good Laboratory Practices, Good Manufacturing Practices, and ISO 9000. Our services in quality assurance and compliance will include:
- Creation, review and evaluations of standard operating procedures
- Review and evaluate design history files and advice clients on improvement procedures, maintenance and completions
- Support manufacturing operations, process analysis, trouble-shooting and process FMEA, as well as process verification, validation, and statistical process support