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Quality Assurance/Quality Control
- Audited active pharmaceutical ingredient, dosage form and analytical laboratories. -- Companies were able to correct deficiencies before PAI.
- Assisted in preparing a new QC Laboratory for FDA Pre-Approval Inspection. -- Site was recommended for approval.
- Recommended efficiency improvements for a QC laboratory. -- Laboratory met tight schedule for product launch.
- Revised and created new SOPs for a QC laboratory. -- Improved procedures led to a successful FDA inspection.
- Reviewed and revised analytical methods and their validations. -- Improved clarity resulted in fewer analyst errors.
- Prepared QA Agreement between the client and a contract laboratory. -- All relevant issues were addressed and the client was protected.
- Trained analysts in SOPs and GMPs. -- Improved skills resulted in fewer deviation reports.
- Reviewed manufacturing batch records and identified GMP problem areas. -- Customized training program was developed based on identified weaknesses.
Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)
- Presented seminars on all aspects of CMC. -- Staff were trained on the latest regulatory requirements and strategies for implementation.
- Prepared CMC templates in Common Technical Document (CTD) format. -- Transition to CTD proceeded smoothly and company met filing deadline.
- Prepared CMC sections of INDs, NDAs and ANDAs including providing regulatory advice, reviewing draft reports, helping firms prepare for FDA meetings, and compiling the final documents. -- Improved CMCs resulted in few questions and companies met tight schedules.
- Reviewed draft NDA. -- Recommended revised regulatory strategy that saved the company $140,000 in user fees.
- Evaluated NDAs and ANDAs versus company practice; advised firms concerning regulatory obligations; and prepared necessary submissions to FDA. -- Firm averted possible, major regulatory difficulties.
- Prepared CMC Regulatory Plan, i.e., list of studies and reports needed for NDA and Pre-Approval Inspection. -- Identified areas overlooked by company.
- Trained regulatory staff. -- Through formal presentations and informal discussions, company staff was able to deal with complex issues.
- Coordinated response to extensive FDA 483. -- Recommendations for ways to address FDA's concerns resulted in improved response.
- Prepared process validation report. -- Report was available for Pre-Approval Inspection.