Our Services

We provide a wide range of services for regulatory projects such as;

  • Registration of NCEs via Centralised, Decentralised, Mutual Recognition and National Procedures
  • Preparation of Orphan Drug Applications
  • In-licensing & Out-licensing
  • Due diligence
  • Training regulatory staff – Introduction to regulatory, mentoring and team support
  • Writing Quality, Non-Clinical and Clinical summaries, overviews, expert statements
  • Preparation and management of applications for Scientific advice EMEA or National
  • Labelling and Compliance

We specialise in:

  • Project Management and support to the generic and non-generic pharmaceutical industry.
  • Global technical and regulatory consultancy. eg, setting up operations in EU.
  • Total management of regulatory affairs.
    • Dossier review
    • Preparation and formatting to CTD
    • Variations
    • Renewals
    • Preparation of scientific and Expert Reports
    • Data Gap Analysis
  • Orphan products.
  • All interactions with Regulators. Eg, scientific advice / responding to questions
  • Risk Management
  • Electronic data management
  • Clinical Trials, GMP, GCP
  • Manufacturing site QA reviews
  • Inspection readiness and Pre-inspection audits

Our Supply Chain Services:

  • Supply chain analysis
  • Outsource management
  • Sourcing
  • Procurement planning
  • Fully compliant electronic service capacities