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.

As the backbone of RCA, our regulatory affairs services are equipt to handle unique regulation challenges in the pharmaceutical industry, from New Product Support to Life Cycle Management. We manage regulatory needs throughout the pharmaceutical industry, such as:
  • Outsourced regulatory affairs and staff augmentation
  • Regulatory gap assessment
  • Site registration
  • DMF: New or eCTD conversion
  • Electronic eCTD preparation and submission
  • And more
Whether you need a regulatory strategy to get a drug approved, an implementation plan for a new project or a corporate needs analysis, RCA's team of seasoned experts provide the insight you need to help you comply with standards, reduce costs, assess personnel and complete other vital tasks associated with strategic planning.
RCA's quality assurance services for pharmaceutical companies include assessment, analysis, implementation and identification of quality metrics for continual company improvement. Our expert team has firsthand knowledge of the steps needed to improve the quality of your organization and will provide you with the services necessary for your pharmaceutical business to implement and maintain this knowledge. Our services include:
  • Outsourced quality support
  • Quality systems implementation, remediation and improvement
  • Risk management ICH Q9
  • Laboratory support
  • And more
With increasing industry compliance demands, life science companies are feeling growing pressure from regulators. RCA's compliance assurance experts help you thoroughly prepare for audits, respond to regulatory agency findings and remedy an unfavorable event through services such as mock inspections, FDA inspection training and implementing a response plan.
At RCA, we understand how significant an impact a compliance crisis can have on your business. We partner with your executive and legal teams to provide the ideal remediation strategy for your situation and assure the best possible outcome.

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