Join Regulatory Compliance Associates (RCA) in Washington, DC or Virtual December 6th and 7th for the FDLI “Enforcement, Litigation, and Compliance Conference: For the Drug, Device, Food, and Tobacco Industries”.

Meet us at FDLI in December 2023 to connect with enforcement consulting Experts from the Regulatory Compliance Associates teams to learn how we can provide you with a complete solution for any of your projects. Together we can confidentially discuss your client and can prepare compliance enforcement solutions to help ensure the safety of their products, process, and organization as a whole.

FDA Consultant

During the FDLI event RCA’s Executive Principal Consultant of Pharma and Biologics, Steven J. Lynn, will be moderating one of the break-out sessions. Steve has over twenty (20) years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries.

Steve is a compliance Expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues. Steve served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA. In the private sector, Steve was an executive at two large multinational corporations and also worked as a consultant for multiple large, mid-sized, and small clients.

Wednesday, December 6^th

 1:30–2:30 PM                  Concurrent Breakout Sessions 1

 Drug Safety Hot Topics: Data-Driven Inspections, Current Good Manufacturing Practice (cGMP) Updates, Nitrosamines, and More

 

About the FDLI Enforcement, Litigation, and Compliance Conference

The annual FDLI Enforcement, Litigation, and Compliance Conference brings together industry, regulators, attorneys, litigators, academics, and consultants to discuss trends and issues in enforcement and compliance, the latest developments in both civil and criminal litigation, and recent cases and settlements. This year’s conference will offer an opportunity to hear from and interact with top officials from FDA, DOJ, FTC, and other government agencies. Hear from your peers about how they are staying compliant and ready for an FDA inspection, what companies need to do to plan for and manage enforcement risk, trends in criminal and civil litigation, and government priorities for the new year.

Conference Highlights:

• Hear about top issues, priorities, and goals for 2024 directly from ORA and FDA’s Center Compliance Directors
• Gain practical tips and best practices on preparing for and managing enforcement and compliance risk
• Learn about trends in government and private litigation

Register Now

 

About RCA’s Pharmaceutical Consulting Services 

Whether you’re in the product planning, development, or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, 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 private equity 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

Regulatory affairs is Regulatory Compliance Associates^® backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. 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 knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

• New Product Support
• Product Lifecycle
• Other Regulatory Services

 

Compliance Assurance

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^®, we offer the experience and resources necessary to guide you in quality compliance.

• Assessments
• Audits
• Regulatory Agency Response
• Preparation and Training
• Inspection Readiness

 

Quality Assurance

Regulatory Compliance Associates^® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. 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 210
• 21 CFR 211
• Data Integrity
• Computerized System Validation
• Manufacturing Support
• Facility Support

 

Remediation 

Regulatory Compliance Associates^® has significant experience and a proven approach 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 RCA

Regulatory Compliance Associates^® (RCA) provides regulatory compliance 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. Our life science consultants 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
• 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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