Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit or developing a response to an FDA finding, Regulatory Compliance Associates® team of compliance consultants can help. Our business consultant Experts are internationally known in the regulatory compliance consulting industry.
Compliance Consulting Services
The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced compliance veteran. If you’re consistently unable to comply with regulations, any notified body can deliver devastating consequences for your business. At RCA®, we offer the pharmaceutical consultants & management consulting resources necessary to guide you in regulatory compliance.
We’re In Compliance
From family-owned enterprises to multinational Fortune 100 companies, we work with all types of pharmaceutical businesses. RCA® Inc. is a certified ISO 9001 organization: we understand navigating the changing demands of FDA, MHRA, Health Canada and other regulatory agencies.
Over 500 industry experts, FDA veterans and consulting professionals oversee our services to ensure that your business is protected to the fullest possible extent. Regulatory policy is what we do – and we do more of it than anyone we know.
Regulatory Compliance Solutions
We offer the following pharmaceutical compliance services to keep our clients out of non compliance:
Assessments
The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA® Inc., our FDA compliance consulting experts have decades of experience in both regulatory compliance program strategy and execution. RCA’s healthcare consulting Experts will help you measure your quality system based on global regulatory markets to assess any process weaknesses and opportunity to improve.
Our range of compliance consulting services include:
- cGMP & Pharmaceutical Manufacturing
- Quality Infrastructure
- PAI, Validation
- Facilities and Maintenance
- Laboratory (GLP)
- Process Assessments to Streamline and Optimize New and Existing Systems.
Audits
Periodic regulatory audits are necessary to both ensure the continued compliance of your organization. An internal audit from a 3rd party business management consultant can help your perspective when it comes to a regulatory audit. Our experienced team of ASQ-CQA and RABQSA certified auditors is available to perform a range of internal audit services, including:
- Supplier
- API
- Contact Manufactures (CMO)
- Internal
- Quality Systems
- Baseline
- Verification
- Clinical (CRO) and Clinical Manufacturing
- Data Integrity
- 503A & 503B
- Combination Products
Regulatory Agency Response
Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. RCA’s strategic consulting Experts can assist you in developing a customized response & plan of action to help remediate the effects of a regulatory warning letter. Our compliance and regulatory services team is here to provide the technical consultant guidance you need most during this time, with response solutions for:
- FDA Form 483
- Warning Letter
- Consent Decree
- Import Bans
Preparation, Training, and Inspection Readiness
Sitting back and hoping for your next regulatory inspection to go well isn’t an option — you need comply with regulations and actively prepare. RCA® will help you thoroughly prepare for inspections with an extensive range of business consulting services, mock inspections and other medical consulting readiness solutions:
- Mock Inspections
- Back Room/ Front Room set-up and process
- Inspection Analysis & Report
- Response Letter Assistance
- Proof Book Development
- Business Relations (Leadership Development Training)
- Corporate Regulation Examples
- Regulatory Law
- Regulatory Board
- Legal Compliance
- Corporate Regulation Examples
- Industry Relations (Leadership Development Training)
- Types of Regulation
- Medical Regulations
- Security Regulations
- Cybersecurity Regulations
- Data Compliance Regulations
- Types of Regulation
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 industry executives of 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 pharma consulting 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 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, 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 pharma consulting 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. 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
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® pharmaceutical industry consultant are quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.
- 21 CFR Part 11
- Data Integrity
- 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. Our pharma consultants 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. 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, Regulatory Compliance Associates® pharmaceutical industry consultant will prepare a comprehensive pharma consulting 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 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, 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.
Commitment to Quality Culture
Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.
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