Global regulatory alliance, from Regulatory strategy to affordable electronic (eCTD) publishing; Agency interactions and representation: Swissmedic liaison, Nigeria’s NAFDAC, South Africa’s MCC; and support for EMA & FDA submissions…Regulatory strategy;

Regulatory road-map;

Submission support;

Agency liaison;

eCTD publishing;

Africa Consult:

 

  • Biologics & Biosimilars;
  • Cell, Gene and Tissue Therapy;
  • Companion Diagnostics;
  • Drug-Device Combinations;
  • Follow-on Biologics;
  • Generics;
  • In Vitro Diagnostics;
  • Medical Device;
  • Microbiome, Nutritionals and Nutraceuticals;
  • Orphan Drugs;
  • Small Molecules;
  • Vaccines;
  • Food and Feeds