Regulatory Compliance Associates® Inc.’s background and experience in the Pharmaceutical industry has helped thousands of companies meet regulatory, compliance, quality assurance, and remediation challenges, in addition to their strategic consulting needs.
With more than 15 years of experience with FDA and other regulatory agencies worldwide, RCA offers leading pharmaceutical expertise to help you navigate through the challenges associated with changing and evolving industry regulations.
Our team of over 500 seasoned FDA compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the FDA. We then use this knowledge to guide clients through regulations regarding Regulatory Affairs, R&D, Manufacturing Operations, Quality Assurance and Compliance.
Whether you’re in the product planning and development 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 pharmaceutical company’s individual needs. Our clients include:
- Companies new to FDA regulations and the pharmaceutical industry
- Start-ups to Fortune 100 multi-national corporations
- Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans
RCA® Inc.’s pharmaceutical regulatory consultants are here to assist you through a range of regulatory and compliance needs. Contact us using the form below to learn more about our industry-leading pharmaceutical regulatory consulting services.
- Outsourced regulatory affairs and staff augmentation
- Regulatory gap assessment
- Site registration
- DMF: New or eCTD conversion
- Electronic eCTD preparation and submission
- And more
- Outsourced quality support
- Quality systems implementation, remediation and improvement
- Risk management ICH Q9
- Laboratory support
- And more