Learn About our Drug Compounding Compliance Services

The FDA’s audit inspection schedule is designed from a risk-based perspective. Drug Compounders who are inspected more frequently have often experienced production or GMP deviations in the past. RCA can partner with your operations team as independent quality control experts to reduce GMP deviations while safeguarding the integrity of your production line.

Additionally, RCA can help your organization prep for regulatory inspections and stay ahead of compliance enforcement. RCA’s outsourcing consulting experts understand how to provide the oversight you need to implement corrective action that remediate problems. RCA’s compliance assurance services include strategy, audit & assessments, and remediation.

Strategy

RCA’s ability to help your leadership team establish compounding quality metrics after implementing a remediation strategy can guide how improvement is measured. Our experts can provide strategic recommendations for achieving sustainable compliance which is personalized from your assessment results.

Audits & Assessments

Understanding how a drug compounders design impacts the quality of the finished product is crucial for maintaining compliance with FDA inspectors.

By leveraging RCA’s expertise, your team can enhance compliance, mitigate risks, and optimize the quality of compounded products. We’ll teach your employees to value the activities performed in the prep, hold and transfer areas of your facility that often lead to quality deviations

Remediation

RCA is widely recognized for its ability to help companies successfully resolve complex compounding scenarios with the FDA. Our value goes beyond the initial response by helping drug compounders execute their plan & develop the long-term compliance strategy. Partnering with RCA offers several competitive advantages in the remediation space.

About Regulatory Compliance Associates

Regulatory Compliance Associates^® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

• Life Sciences
• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

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, Regulatory Compliance Associates 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 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

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.