We are the specialists in navigating your drug and device products through the FDA and EMEA Licensing process and specialise in Statistical Support. Our support comes from those who have first hand experience working in a major health regulatory agency (e.g. FDA, EMA, MHRA). In addition, the experts we provide include expertise in HTA and reimbursement across multiple countries.

  • FDA
  • EMA
Statistical Services

Statistical Services

  • Drug Licensing
  • Devices Licensing
  • Advice for Inspections
  • Writing Briefing Books
  • Writing Protocols
  • Statical Sections of Protocols
  • Regulatory Statistical Consultancy
  • Reimbursement Advice
  • Pharmacokinetic
Disease Areas Covered

Disease Areas Covered

  • Oncology and Immuno/Oncology
  • Cardiovascular
  • Gene Therapy including ocular disorders, Haemophilia
  • Endocrine
  • Neurology
  • Dermatology
  • Nephrology, Hepatology
Additional Services

Additional Services

  • Statistical Programming Support in SAS and R : We can either take on your SAS Programming or provide you with experienced SAS programmers
  • Early Phase and Late Phase Support
  • Health Economic Modelling : Statistical support for Health Economics and Real World Data

Medical Devices and Diagnostics

  • Imagine Modalities
  • Imaging Agents
  • Devices and Testing
  • Biomarker Testing
  • PCR Testing Devices
  • COVID -Testing
  • European Medicines Agency COVID-19 Data Analyses Collaboration

COVID19

  • PCR Testing Devices – collaboration with academic centres (Warwick university : cost-effectiveness)
  • European Medicines Agency COVID-19 Data Analyses Collaboration
  • COVID-19 Research Analyses with visually impaired and Disabled  (Blind Ambition)
Training

Training

  • Statistical Training For Drug and Device Registration and Licensing
  • Statistics Courses for GCP
  • Statistical Consultancy
  • Statistical courses for Devices and Diagnostics
  • Health Economic Training
  • Health Economics and HTA consultancy

Register for Economic Evaluation of Cancer Drugs March 2022 TBC Watford Mercure Hotel

Previous Experiences with

  • Pfizer
  • Lilly
  • Eisai
  • GW
  • BMS
  • Merck