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