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About us

Innovative Regulatory Affairs Strategies for Innovative Products

EU/UK Legal Representative Services

We were established in 2006 to provide a specialist Legal Representative service for non-EU clinical trial sponsors. Many of our first clients remain working with us today as we have grown alongside them to fit their evolving needs and developed a complete regulatory affairs service offering. Our expert team works closely with our clients to ensure compliance with all relevant EU and national legislation as it changes.

Our Management Team

  • Chairman

    Dr Francisco Harrison

    Over 30 years’ experience in management and operation of clinical trials including as Chief Investigator for multi-centre trials. Founder & board-level management of several diverse companies within the pharmaceutical & biotech industry, including Harrison Clinical Research (CRO, now SynteractHCR).

  • Managing Director

    Tamsyn Frost, PG Dip

    Regulatory Affairs professional with over 10 years’ experience in global regulatory projects in the pharma-ceutical and biotechnology industries. PgDip in Regulatory Affairs and a solid understanding of regulatory strategy, clinical trials and orphan drug development.

  • Principal Scientific Advisor

    Randolph Alonso, PhD

    Regulatory Affairs Pharmacist with more than 26 years’ experience in pharmaceutical companies in EU and LATAM regions. Exceptional track record of life cycle management of pharmaceutical, biological, biosimilar and generic products and a thorough understanding of the global regulatory environment.

  • Commercial and Operations Director

    John Farrell,
    MSc

    Over 30 years experience in delivering professional services to Pharmaceutical, biological and medical device clients. Former Global head of Life Sciences Business Process Outsourcing at CSC and Former COO at Product Life Group

Our trusted partners

We are experts in our specialist service areas. For other services, we have sought to build a network of expert partners who share our commitment to delivering focussed expertise. Currently, we can recommend partners in the following areas:

  • GDPR
  • Pharmacovigilance – Both Clinical Trial and Marketed product
  • CROs
  • Third-Party GxP Audit
  • Medical Writing
  • Market Access
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