Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
Our Quality Assurance services for the pharmaceutical industry include:
- Outsourced Quality Support – Interim Management, staff augmentation or outsourcing quality and regulatory management has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the lifecycle of the organization. These companies turn to outsourcing to manage operations and tactical skills and also help adopt best practices.
Early in a company’s lifecycle, strategic leadership is needed for product filings, regulatory pathway, manufacturing setup, and quality management systems creation. As the company matures, these functions often transition to a maintenance mode.
Outsourcing strategic management can provide a better match to changing QA / RA strategic needs through a company’s lifecycle. Our interim management brings needed expertise while saving costs.
- Quality System Automation Using Software
- Quality Systems Implementation
- Quality System Remediation / Improvement
- Risk Management ICH Q9 – We can provide you with the staff and tools needed to implement or remediate your quality systems to current industry standards and train your personnel to manage it.
- Corrective and Preventive Action (CAPA) and Complaint Systems – We manage implementation and remediation of CAPA systems and Complaint Handling Systems.
- 21 CFR Part 210 and 211
- EU Good Manufacturing Practice (GMP)
- Computerized System Validation Standard Operating Procedure (SOP) – Our computer validation experts and software engineers have extensive experience with the GAMP5 validation model to ensure that you have the appropriate level of documentation.
- Laboratory Support
- SOP Development
- Method Transfer
- Method Validation