About MBA

REGISTRATION REGULATORY AFFAIRS – REIMBURSEMENT DEVELOPMENT

Martin Biggs Associates is a healthcare / regulatory affairs consultancy with over 30 years experience. We can provide advice and assistance with European, Australian, South African, Chinese and US – FDA authorization of drugs, devices, drug/device combinations, IUDs, and cosmetics.

  • Drug / Medicinal Product registration in Europe and other territories
  • CE marking / Medical Devices
  • FDA Drug and Device registration
  • Reimbursement of Drugs / Devices / Borderline Products / Food Supplements
  • In vitro Diagnostics registration
  • Stategic business planning and acquisitions
  • Trademark searches and registration
  • Patent and distributor searches
  • Patenting – intellectual property management and marketing advice
  • EU Cosmetics Directive
  • Expert reports
  • Advice as to choice of Notified Body and Competent Authority
  • Advice on the most cost effective route to CE marking and the choice of Annex
  • Selected List Scheme (SLS) and the Pharmaceutical Price Regulation Scheme (PPRS)
  • Due diligence studies / risk analysis studies
  • Authorized Representative services for Drugs, Devices, and Cosmetics
  • Expert witness service
  • Strategic marketing / pricing
  • Are you having difficulty in obtaining listing of your product in the Drug Tariff?
  • Do you need assistance with defending your brands against generic competition?
  • Do you need advice on NICE cost-effectiveness reviews?

 

Consult us on a strictly confidential basis

Others do and have found our services profitable

We are active participants in the Drug Tariff Forum, which meets under the auspices of the ABPI, and a member of the Expert Witness Institute.