Regulatory Affairs

Full Regulatory Support for API Developers and Manufacturers.
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Leverage Regulatory Strategy

To successfully comply with regulatory requirements and avoid penalties, rejection and delays, Life Science businesses need to be aware of the challenges posed by different laws operating in different market regions.

Don’t risk losing quality and trust: choose the right training, guidance and support.

Regulatory Affairs Pharma

Pharma support

  • Regulatory Strategic Master Plan and Feasibility Studies
  • Bioequivalence Study Designs review
  • Full Development Plan
  • IND/IMPD compiling
  • Scientific Advice, Protocol Assistance & Parallel Advice requests
  • M&A Due Diligence SupportDrug Development Trainings

  • Full support for medicinal product registration
  • Drug life-cycle management: Variation/Change Application Dossier, EU renewals, EU line extension
  • Promotional activities: Regulatory review and support for Approval of Advertising, Educational Material to HCP/HCO, Scientific Service Quality System
  • Dossier reformatting & Electronic submission
  • Regulatory Department Compliance Assessment

Regulatory Intelligence

We can provide regular updates, to make you aware of regulatory requirements applicable to your portfolio, and insights on the expectations of the regulatory authorities.

All in your first language.

Regulatory Affairs Intelligence
Regulatory Affairs MD

Medical Device support

  • US Agent
  • 510K
  • Device Listing
  • Establishment registration
  • Regulatory intelligence
  • Regulatory strategic plan
  • Technical File preparation

  • Compliance Support Consultancy
  • Clinical Preparation
  • Performance Evaluation Plan
  • Post Market Follow Up
  • Post Market Surveillance
  • Manufacturers and Device Registration
  • Recording and Reporting Incidents
  • Implementation of Unique Device Identification (UDI)
  • Device Classification
  • Assessment

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Get in touch.

To easily navigate the increasingly complex regulatory market and sell your products in EU, US and Canada, LATAM, MENA, CIS, Africa and APAC.