Regulatory affairs is Regulatory Compliance Associates (RCA®) backbone and we fully understand the complexities of the pharmaceutical industry and biotechnology industry. Our team of regulatory consultant Experts span all facets and levels of regulation, from Regulatory Support for New Products to Life Cycle Management, to other services like outsourced Regulatory Affairs, regulatory agency submissions, legal regulation training, and more.
Regulatory Consulting Services
As your regulatory affairs specialist and Expert partner, Regulatory Compliance Associates can negotiate the potential assessment minefield of pharmaceuticals with the advantage of deep management consulting experience. We offer the following four regulatory affairs services for pharmaceutical companies & pharmaceutical science organizations.
New Product Support
Regulatory Compliance Associates gives you the industry guidance and regulatory consultants you need to succeed throughout the pharmaceutical regulatory affairs process. While other consulting firms have good ideas, RCA’s regulatory consultant Experts can support your new products through the research and approval process to comply with regulated industry guidance. Our regulatory consultants can help your leadership team strategize about late-stage development, drug regulatory affairs, and how evolving regulatory science trends are shaping the industry.
Our regulatory compliance consulting expertise includes a comprehensive understanding of the regulatory framework of regulatory agencies for New Product Support services, such as:
- Regulatory meetings and briefing packages
- BLA meetings
- Type A, B, or C meetings
- Advisory meetings
- Health Canada, MHRA, and global submissions or dossiers
- U.S. FDA submission — IND, DMF, BLA, ANDA, NDA — and combination products
Product Lifecycle Management
Our regulatory consulting team of seasoned experts can serve your needs, even if your product is already on the market. Whether you need dossier content management, regulatory standards updates or experts to assist with transitional periods in your business, RCA® is your go-to source for knowledgeable compliance experts across the regulatory system.
Our Regulatory Compliance Associates Expert consulting life cycle management services include:
- Pharmaceutical research
- Staff Augmentation
- Dossier/application management
- Global change control
- GMP’s for early-stage development
- eCTD and Electronic Submission Capabilities to the U.S., Canada, and the EU
Other Regulatory Services
At Regulatory Compliance Associates, we understand client needs are not one-size-fits-all throughout the pharmaceutical industry. We offer an array of regulatory services differentiated based on drug companies and unique medical consulting. Our regulatory consultants lead training programs, dossier and submission preparations, interim management assistance, and more.
Some of the many additional regulatory compliance consulting services we offer include:
- Outsourced regulatory services
- New dossier and DMF or conversion to eCTD
- Electronic eCTD preparedness and submission
- Regulatory affairs training
- Site Registrations
U.S. Agent Services
As part of our regulatory consultant services, we offer assistance with registration and services for a global pharmaceutical drug you wish to sell in the U.S. As a registered U.S. agent, Regulatory Compliance Associates will expertly handle FDA interactions for international companies selling imported drugs.
Our role as a U.S. agent allows us to:
- Assist with FDA communication on a foreign company’s behalf
- Answer questions about the drugs being imported into the U.S.
- Aid in scheduling FDA facility inspections
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, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.
Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows 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, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:
- Companies new to FDA, Health Canada or EU regulations and regulatory compliance
- 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 pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans
Regulatory Affairs
Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.
As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting 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. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.
- Assessments
- Audits
- Regulatory Agency Response
- Preparation and Training
- Inspection Readiness
- Data Integrity
Quality Assurance
Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.
- 21 CFR Part 11
- Data Integrity
- Manufacturing Support
- Facility Support
- Quality Metrics
Remediation Services
Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.
Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.
- Regulatory Action
- Regulatory Compliance
- Regulatory Enforcement
- Warning Letter
- 483 Observation
- Oversight Services
- Risk Management Plan
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.
