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REGULATORY AFFAIRS &
CLINICAL COMPLIANCE

Strategic Consulting Solutions

Strategic Consulting & Solutions

We strive to provide a complete suite of regulatory compliance services focused upon consulting and advisory solutions for advanced, integrated, and robust pre-market strategies; and areas including, regulatory product development phases (PDP), quality management systems (QMS), clinical development, regulatory filings/submissions, post-market compliance and product lifecycle management (LCM).

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Regulatory Affairs Services

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The regulatory consulting services include both premarket and post-market strategies. Pre-market submissions strategies include:

Domestic & International Registrations:

US FDA, CANADA, EU, EMEA, LATIN AMERICA (LATAM), ASIA-PACIFIC (APAC), JAPAN, & ROW geographies.

Additional Topics:

Labeling Compliance (Medical Devices, Pharmaceuticals sector)
Advertisement & Promotional Materials guidance 

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The regulatory consulting and strategies for the pre-market submissions include:

Pre-Clinical Compliance & GLP Studies

  • Product Development Process (PDP)

  • Biocompatibility Testing (& Toxicology) planning

  • Pre-clinical studies protocol development

  • Technical guidance

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Pharma/Biotechnology Sector

  • NDA/BLA Submissions support.

  • Supplements

  • Annual Reports

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Medical Devices Sector

US FDA Submissions

  • Pre-submissions/Q-Subs

  • 510ks

  • PMA

  • De Novo

  • Pre-IDE, IDE

  • HDE

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EU Submissions

  • CE Marking Application

  • EU Technical Files

  • EU Design Dossiers

  • EU MDR Compliance

  • MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for Medical Devices

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Health Canada

  • New Class II License Applications, Class III and Class IV License Applications, including significant changes.

  • Class II License Amendments

  • Labeling Amendments Application

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International Registrations

  • JAPAN

  • EMEA, Middle East

  • LATIN AMERICA (LATAM)

  • ASIA-PACIFIC (APAC)

  • ROW Geographies​

Clinical Compliance

We provide guidance and consulting services for the following:

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  • Good Clinical Practice (GCP) Compliance

  • Due diligence 

  • IDE Compliance  

  • MEDDEV 2.7.1 rev 4 Guidance, and Clinical Evaluation Reports (CER) for Medical Devices

  • MEDDEV 2.12/2 rev2., Post-market Clinical Follow-up. 

  • Post-market Clinical Follow-ups Compliance.

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Ensuring full regulatory compliance for Good Clinical Practice (GCP), and clinical documentation contents for the investigational phase submissions and regulatory filings.

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Global Regulatory Affairs

The global pre-market and post-market compliance requires that the medical products harmonize and meet with the regulatory safety and efficacy throughout their life cycle for the commercial use. Multiple aspects need to be considered when registering a medical product in the international/global markets which includes maintaining compliance with the newly formed or changing regulations and country-specific laws. We provide services to meet the new norms with regulatory submission strategies and post-market solutions.

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