Regulatory Compliance Associates® Inc. has the expertise to assist you with your unique regulatory needs. We understand that it’s not always submissions and inspections that companies might need assistance with, but other areas that support your business operations.

As your U.S. Agent, we provide assistance with U.S. registration and service for your pharmaceutical product.

 

 

  • Outsourced Regulatory Services—We can assist Interim Management situations such as: the company’s VP of Quality and Regulatory unexpectedly submits notice, or another key QA staff member takes medical leave, or the start-up company needs strategic RA / QA insights, but isn’t ready for full-time headcount. Regardless of the size of the life science company, outsourcing quality and regulatory management can bring needed expertise while saving costs. We can provide outsourced management solutions to:
    • Operations
    • Quality
    • Regulatory
    • Medical Affairs
    • Product Development
  • Regulatory Gap Assessments or Regulatory Due Diligence Audits
  • Change Control Support
  • Regulatory Affairs Training—Proper training is key in a regulated environment. We have a training program that suits your professional needs, company goals, and preferred learning style.
    • Good Manufacturing Practice (GMP) Fundamentals
    • Quality System Regulation
    • International Medical Device Regulations
    • Good Documentation Practices
    • Quality Management Systems and Infrastructure
    • Management Responsibility
    • Risk Management
    • Complaints and Medical Device Reporting (MDRs)
    • CAPA and Root Causes Analysis
    • Design Control
    • Validation
    • Environmental Control
    • Calibration / Maintenance
    • Purchasing Controls and Supplier Management
    • Change Control
    • Document Control
    • Regulatory Submissions 510(k)
    • Non-Conforming Product
    • Technical Writing
    • Audits
    • Adverse Finding and Consequences
    • Criminal Offenses
    • Contributing To A Successful Quality Culture
  • Electronic Submissions Preparation in Electronic Common Technical Document (eCTD) format for FDA, Health Canada, and EMEA

 

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