Regulatory Compliance Associates® Inc. can help with remediation activities in the areas of manufacturing operations and quality systems. We have completed many pharmaceutical oversight projects assisting our clients in evaluating what is needed, determine action plans and provide assistance to execute. We have also performed post-implementation audits to ensure effectiveness of improvements.
RCA can assist you and your organization in:
- Auditing capabilities to understand and verify if there is a gap in compliance within manufacturing operations and any Quality area
- Developing specific strategies and defining tactical actions for current good manufacturing practice (cGMP) areas to regain compliance with U.S. and other regulated bodies
- Guiding and leading implementation for improvement efforts in:
- Manufacturing shop floor pharmaceutical oversight
- Quality systems: quality control, quality assurance, document control, investigations, and corrective and preventive actions (CAPAs), batch record review and release
- Supporting departments and activities: preventative maintenance / calibration, warehousing, vendor auditing, etc.
- Performing oversight activities for manufacturing / production and quality control (QC) testing
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.