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Procedure Management

It is essential, after the expense and hard work that goes into completing your pre-submission phase, that you have in place a dynamic regulatory strategy to ensure that your investment is maximised i.e. one that gets you to market faster. Our technical team can advise on the best regulatory strategy to help realise your products full potential.  Ranging from advice on Product Development through to using our  extensive knowledge of the centralised, decentralised and mutual recognition procedures in Europe and of all other major regulatory requirements worldwide, our team can help you plan your submission routes and define which  countries you should access first.

Cambregs experts can advise on all or part of the regulatory process which may include;

  •       Product Development
  •       Whether or not Orphan Drug Designation is a possibility
  •       Legal Basis of application 
  •       Regulatory submission routes
  •       Choice of Reference  Member State/Concerned Member States
  •       World Market Access plan
  •       Legal Status switch (eg Prescription Medicine to Over  The Counter (OTC))
  •       Increased scope of MA eg addition of paediatrics
Orphan Drug Sector Information
Scientific Advice Sector Information
National / DCP / MRP Sector Information
Centralised Procedure Sector Information