Exponent has successful experience with the regulatory agency interactions and communication with healthcare professionals for new single entity as well as fixed-dose combination product submissions. We can help you devise, implement, and execute regulatory strategies for the development of small molecule drugs and biologics and for successful product registrations in the U.S. and internationally. We also assist clients with regulatory non-conformity issues such as 483 and FDA warning letters, as well as product recall situations.
We 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 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
Regulatory and Quality Assurance Support Services
- 505(b)1, 505(b)2, 505(j)
- Data gap analysis to assess submission requirements
- Strategic support for determining type and timing of regulatory submissions and meeting preparation
- Serve as U.S. agent for non-U.S. companies with FDA submissions
- Preparation and assembly of regulatory submissions (IND/NDA, CTA/MAA, BLA, ANDA etc.)
- Drug Master File (DMF) assembly
- Preparation of other regulatory submissions i.e., annual reports, labeling revisions, amendments and supplements (e.g., PAS, CBE-30)
- Devise regulatory strategies for development of small molecule drugs and biologics for successful products registration in the US and internationally by working alongside 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 guidance(s)
- Support the development of the CMC section of regulatory submissions
- Coordinate, attend 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
- Risk Evaluation Mitigation Strategy (REMS) development, conduct and analysis
- Postmarketing pregnancy registries
- Analyze adverse event reports, identify specifics products or lots to be recalled
- Implement Corrective and Preventive Action (CAPA) plans, including root-cause analysis