Pharmaceutical Consultants

pharmaceutical consultants Regulatory Compliance Associates^® (RCA) provides pharmaceutical consulting & 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. 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.

About RCA’s Pharmaceutical Consulting 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 evolving industry regulations.

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and pharmaceutical consultants can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process.

Client Solutions

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, RCA^® Inc. 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^® Inc.’s 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
Combination Products

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 Regulatory Compliance Associates, our pharmaceutical consultants offer the experience and resources necessary to guide you in quality compliance.

Assessments
Compliance Audit
Internal Audit
Regulatory Agency Response
Preparation and Training
Inspection Readiness
Data Integrity

Quality Assurance

Regulatory Compliance Associates^® Inc.’s 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 life science consultants 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
Quality Metrics

Remediation Services

Regulatory Compliance Associates^® has significant experience and a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that the regulatory agency will accept 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
Regulatory Compliance
Regulatory Enforcement
Warning Letter
483 Observation
Oversight Services

Strategic Consulting

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates^® life science consultants can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

Our 500 industry and FDA experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

Manufacturing Optimization
Product Lifecycle Management
Mergers & Acquisitions (M&A)
Due Diligence
Device Vigilance
Product Complaints
Risk Management Plan

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.