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
About Regulatory Compliance Associates
Regulatory Compliance Associates (RCA) provides healthcare consulting 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, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.