M&A Consulting for the Life Science Industry
Many companies move forward on pharmaceutical deals without a clear picture of their risks. A healthcare due diligence process that’s too high-level or superficial is often to blame. And, when healthcare mergers don’t deliver value, the real causes are often strategic, cultural, or technical. Rather than taking this risk, ensure the highest chances of your merger and acquisition strategies success increases with a pharmaceutical due diligence consultant like Regulatory Compliance Associates®.
Mergers and Acquisitions
Our experience in the evolving specialty of Mergers and Acquisitions can help ensure a successful mix of people and product, so you’re never embroiled in a costly mistake. We employ more than 500 subject matter experts with an average of 25 years of business mergers experience. Your team can rest assured your due diligence will be performed as thoroughly as possible for results that will benefit your business for years to come.
Healthcare Due Diligence
RCA® offers numerous mergers and acquisitions consulting services to ensure the value of your prospective business procurement. Our Mergers and Acquisitions / Due Diligence services for the Pharmaceutical industry include:
- Regulatory Due Diligence: Regulatory due diligence involves completing an in-depth assessment of a business’ regulatory compliance. We’ll dive into the history of the company in question to search for any FDA compliance concerns and evaluate current regulatory practices that might put a financial strain on your business.
- Quality: Quality due diligence is an in depth assessment of the quality management system. We will use this information to help you understand if the company has and is following their standard operating procedures and processes.
- Facility / Equipment Assessment: One vital yet often-overlooked aspect of due diligence is an assessment of the company’s facilities, equipment and business procedures. We’ll help you evaluate whether a pharmaceutical company’s facility and machinery are safe, reliable and compliant.
- Personnel Assessment: Likewise, we can help you assess the leadership skills of the business’ management personnel as well as the personnel within each department. Whether you are evaluating if managers are communicating effectively or whether your have the right number of resources or skill sets, you’ll gain insights that will help you make critical judgments once your acquisition is complete.
- Post-Merger Integration and Compliance Strategy: The merger or acquisition process doesn’t stop immediately after making a deal. Its success or failure largely depends on how effectively you can integrate afterward. We’ll help you share and manage data, increase collaboration across teams and learn new skills for making your deal a success.
- Risk Identification and Mitigation Planning: Before, during and after you make a deal, we’ll help you identify all risks and make any adjustments necessary in the integration process. You’ll be better able to mitigate these risks before they significantly impact your bottom line.
Mergers & Acquisitions Industry-Leading Support With RCA®
If you’re in the process of looking for due diligence in mergers and acquisitions, you need a partner you can trust. RCA® Inc offers support services that span the due diligence process and M&A integration. You’ll enjoy the advice of industry experts and FDA veterans who can determine the risks of your potential procurement and make integration as seamless as possible.
About RCA’s Pharmaceutical Services
Regulatory Compliance Associates (RCA)® has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with the largest acquisitions.
Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding healthcare mergers and acquisitions and the unique inner workings of the regulatory process.
When you’re in the merger and acquisition process, RCA® will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:
- Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
- Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
- Investment firms seeking acquisition due diligence for pre-acquisition and post-deal research
- Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans
Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical merger strategies. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.
As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of successful mergers and acquisitions. We offer the following four regulatory affairs services for pharmaceutical companies.
- New Product Support
- Product Lifecycle
- Other Regulatory Services
The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the post acquisition integration resources necessary to guide you in quality compliance.
- Regulatory Agency Response
- Preparation and Training
- Inspection Readiness
Regulatory Compliance Associates® Inc.’s Quality Assurance services go beyond what the common M&A consulting firms choose to examine. Our solutions include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. RCA clients benefit by aligning with your business needs and portfolio goals early in the M&A acquisition. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
- 21 CFR Part 11
- Data Integrity
- Manufacturing Support
- Facility Support
Regulatory Compliance Associates® Inc. has significant mergers & acquisitions consulting experience to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute.
We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.
- Regulatory Action
- Warning Letter
- 483 Observation
- Oversight Services
About Regulatory Compliance Associates
Regulatory Compliance Associates (RCA) provides healthcare consulting services to the following industries for private equity mergers and acquisitions:
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.
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