G&A Associates
API development and regulatory support firm focused on supplying ANDA and NDA holders. Services emphasize integrating regulatory and cGMP compliance into development workflows to support transition from sample development through scale-up, validation, regulatory submission, inspection management, and commercial launch.
Industries
N/A
Nr. of Employees
small (1-50)
Services
Technical development of API processes with regulatory considerations embedded to support regulated submissions and manufacturing scale-up.
Support for scaling API processes and executing validation activities required for commercial launch.
Compilation of regulatory submissions including DMFs and management of responses to regulatory deficiencies.
Implementation of a Six Systems-based compliance program with scheduled audits and partner training to meet cGMP and inspection readiness.
Support during regulatory inspections including translation services and assistance preparing responses to Form 483 observations.
Technical development of API processes with regulatory considerations embedded to support regulated submissions and manufacturing scale-up.
Support for scaling API processes and executing validation activities required for commercial launch.
Compilation of regulatory submissions including DMFs and management of responses to regulatory deficiencies.
Implementation of a Six Systems-based compliance program with scheduled audits and partner training to meet cGMP and inspection readiness.
Support during regulatory inspections including translation services and assistance preparing responses to Form 483 observations.
Expertise Areas
- API development for regulated markets
- Regulatory compliance and DMF/ANDA support
- cGMP compliance and audit management
- Process scale-up and validation
Key Technologies
- Active pharmaceutical ingredient (API) process development
- Process scale-up methodologies
- Process validation techniques
- Regulatory dossier preparation (DMF, ANDA support)