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ACCUREG INC   |   13762 W STATE RD 84   |   SUITE 616   |   DAVIE FL 33325   |   954-641-6400   |  accureg@regulatory.com

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 REGULATORY, COMPLIANCE AND TECHNICAL

SERVICES

Diversity - of breadth, depth, complexity, criticality, timing, staffing, funding, and more. Diversity is a great word to sum up the extraordinary universe of medical product projects. Project requirements differ - a short and simple sentence that says a mouthful. Projects may share similarities, but none are completely alike.

 

Your project may require a short-term triage. Or you might need the long-term immersion of a team. Maybe you're seeking one focused, experienced professional to fill a critical role, or simply the assurance of the right answer to a pivotal question that is rate-limiting the whole team. The bottom line is:  Whatever the scope of your project, you need what you need.

AccuReg S4 Compliance, FDA Regulatory & Compliance Consulting

AccuReg offers a full range of consulting and technical services, ranging from guidance and advice, to on‑site collaboration and training, to turn-key delivery. And no matter the size - on projects large or small - our S4 Compliance Process applies to everything we do. Follow the links below for more information about our core service areas:

Quality Systems Compliance, Implementation and Remediation Plans using the S4 Process

  • Including Extended Quality System Plans for Warning Letter and Consent Decree Remediation (AccuReg is an FDA-recognized Consultant of Record)

AccuReg S4 Compliance, FDA Regulatory & Compliance Consulting, Quality Systems

Inspection Readiness, Coaching and Preparation

  • Including Agency Liaison (Direct Interface with Regulatory Agencies
    on Behalf of Clients)

AccuReg Inspection Readiness, FDA Regulatory & Compliance Consulting

Audits and Gap Assessments

  • GxP, ISO, Bioequivalence/Biosimilar, Due Diligence, Vendor/Supplier

AccuReg GMP, GCP & ISO Audits, FDA Regulatory & Compliance Consulting

Regulatory Applications and Submissions

  • IDEs, PMAs, 510(k)s, INDs, NDAs/ANDAs, BLAs, DMFs, CMCs and More

AccuReg Product Approva, FDA Regulatory & Compliance Consulting, Regulatory Submissions

Software and Computer Systems Quality and Validation

  • Quality Assurance, Validation, Part 11 Compliance, Design Control, Risk Management and More

AccuReg Software Validation, Software Quality, FDA Regulatory & Compliance Consulting

Clinical Research Services

  • Clinical (GCP) Auditing and BIMO Auditing, Study Design and Review, CRF Development,
    Pre-IND/IDE Meetings and More

AccuReg GCP BIMO Audits, Good Clinical Practices, FDA Regulatory & Compliance Consulting