Regulatory Affairs Consulting

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

  • Manage product’s approval and registration​
  • Speed up product's launch​
  • Reach different countries and assure global coverage​
  • Consistently keep products on the market​
  • Coach R&D to collect the right data from the first stages​
Regulatory Affairs for Pharma & API
Regulatory Affairs for Medical Devices & IVD
Clients that trust us
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Years of experience
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Projects executed
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Offices worldwide
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Pharma and API Regulatory Affairs 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
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Medical Device Regulatory Affairs 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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EU MDR IVDR
EU MDR & IVDR Consulting​

Regulatory support to any Medical Device or IVD businesses looking to launch on the European market, needing guidance with CE Markings or wanting to ensure business continuity and renewal.

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FDA-510-K
FDA 510(k) Consulting​

From establishment registration, 510(k) preparation and submission, quality system implementation, inspection support, design controls, and supplier evaluation, to process validation.

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Regulatory Intelligence

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.​​

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.​

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To easily navigate the increasingly complex regulatory market and sell your products in EU, US and Canada, LATAM, MENA, CIS, Africa and APAC.
  • Trusted by 540+ clients
  • 25+ Years Experience
  • 15,000 Projects Executed
  • 45 Offices Worldwide

ISO 9001 Certified compliance services provider since 1998.

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