Regulatory Compliance Associates knows how quality or compliance crises can significantly impact your business—and we have the experience to manage those crises. Our areas of expertise include identifying and assessing any deficiencies to help determine the best approach and compliance assessment solutions. We can perform a “deep dive” into any quality system or process that you feel needs a good top-to-bottom assessment.
While not an all-inclusive list, our Compliance Assurance Assessment services for the Pharmaceutical industry include:
- Current Good Manufacturing Practice (cGMP)
- International Organization for Standardization (ISO)
- Quality Infrastructure
- Corrective and preventive Action (CAPA)
- Validation
- Facility and Maintenance
- Pre-Approval Inspection (PAI)
- Data Integrity
- Start-up Assessments
Pharmaceutical Mergers & Acquisition / Due Diligence
When a life science company considers a merger or acquisition, it is easy to think of the deal’s risk as a potential conflict with the FDA or its equivalent in other countries. The due diligence team looks for 483s, Warning Letters, notified bodies and findings, and product recalls. But more often, the real reasons a deal doesn’t deliver value are strategic, cultural, or technical. It’s these value-destroying areas that need to be explored during due diligence. We can help a company make the right decision.
We leverage our global experience with acquisitions and divestitures to navigate the gray areas of due diligence and help eliminate uncertainties often inherent in a complex deal. These include:
- Regulatory Due Diligence
- Quality Due Diligence
- Facility / Equipment Assessment
- Personnel Assessment
- Risk Identification and Mitigation Planning
- Post-merger Integration
- Compliance Assessment
Additional services related to assessments include:
- 21 CFR Part 11 / Annex 11 Assessment
- 21 CFR Part 210 and 211 Assessment
- Good Laboratory Practice (GLP)
About Regulatory Compliance Associates
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for the 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.
