Quality & Regulatory Management
Consulting firm providing technical services, regulatory strategy, quality systems, analytical and validation support, process development, and customized training to pharmaceutical and biopharmaceutical companies. Services cover discovery through commercialization, including regulatory filings, quality system implementation, contract-facility oversight, and preparation for regulatory inspections.
Industries
Nr. of Employees
small (1-50)
Quality & Regulatory Management
Westlake Village, California, United States, North America
Services
Strategic regulatory planning, filing preparation and management, meeting preparation, and responses to regulatory inquiries.
Design and implement phase-appropriate quality systems, manage QA operations, and perform audits and compliance improvement.
Establish CGLP/CGMP testing capacity, develop and transfer analytical methods, and set specifications and protocols.
Implement validation master plans and execute validation for equipment, cleaning, computerized systems, analytical methods, processes, and facilities.
Support process optimization, characterization, and QbD-driven development and evaluation.
Evaluate, select, audit, and manage CROs/CMOs, and develop/negotiating contracts and quality agreements.
Strategic regulatory planning, filing preparation and management, meeting preparation, and responses to regulatory inquiries.
Design and implement phase-appropriate quality systems, manage QA operations, and perform audits and compliance improvement.
Establish CGLP/CGMP testing capacity, develop and transfer analytical methods, and set specifications and protocols.
Implement validation master plans and execute validation for equipment, cleaning, computerized systems, analytical methods, processes, and facilities.
Support process optimization, characterization, and QbD-driven development and evaluation.
Evaluate, select, audit, and manage CROs/CMOs, and develop/negotiating contracts and quality agreements.
Expertise Areas
- Regulatory compliance and strategy
- Quality systems development and audit readiness
- CMC and process development
- Analytical method development and validation
Key Technologies
- GxP compliance (GMP/CGLP/CGCP)
- Regulatory submission preparation (IND/NDA/BLA/ANDA/DMF)
- Analytical method development and transfer
- Stability testing and protocol management