Share Our Information
Pre-Acquisition Technical Due Diligence
Background
A private equity firm was negotiating to purchase an established medical device company. Regulatory Compliance Associates® Inc. (RCA) was contracted to provide private equity due diligence and technical analysis of facilities, manufacturing, quality, and regulatory systems, as well as the technical infrastructure.
RCA planned and executed the due diligence process against a tight timeline.
Challenge
Under time constraints and with limited access to information, RCA needed to identify the compliance, regulatory, technical, and operational risks associated with the pending purchase. RCA also was charged with identifying remediation costs that could be used during deal negotiations.
Approach
RCA planned and executed the due diligence process against a tight timeline. Regular communications were established with the client and other external due diligence teams, including legal, IT, and insurance.
- For each area of technical focus, checklists and cross-functional items were determined to ensure proper organization and thoroughness of the process
- An advance team conducted a preliminary evaluation, requested documents, and prepared the target site for the specialized due diligence team
- Due diligence was conducted at both domestic and international sites, and a report was submitted that included estimated cost to remediate the issues
- Post-report meetings with the client discussed risks, costs, potential action plans, and impact on deal negotiations
Result
RCA identified key business, technical, regulatory, and quality issues impacting the deal. The issues were risk mapped with remediation recommendations and accordant costs. The client used this data to discount the purchase price, negotiate escrow funds, and understand the way forward after deal closure.
About RCA
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 RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
References
- FDA Code of Federal Regulations, Title 21, Part 820, “Quality System Regulation,” April 1, 2010.
- International Standards Organization, ISO Standard 13485: Medical devices—Quality management systems—Requirements for regulatory purposes. Second Edition, July 15, 2003.
