Regulatory Affairs, Pricing, Reimbursement & Market Access


Services


Regulatory Affairs:

  • Strategy in Pharma, Biotech and Medical Devices
  • Preparation of roadmaps and development plans for biotechs and medtechs
  • Scientific Advices on AEMPS and EMA. Orphan Drug Designations for EMA and FDA
  • Company & Dossier Due Diligences
  • Medical writing: IMPD, IB, CTA, record modules
  • EU procedures (CP, DCP, MRP, NP). eSubmission
  • Technical Files, 510k and PMA devices for Class I, II, III and diagnostic kits
  • Strategic partnerships with our worldwide network of partners (EU, U.S. and LATAM)

In this regard, Antares Consulting is "full member" of regulanet® , an international consortium of companies specializing in regulatory affairs consulting offering services worldwide to Pharma , Biotech and Medtech Companies . With this partnership we are able to work in more than 90 countries to develop our expertise in Regulatory Affairs, and we strengthen our portfolio services in the regulatory environment, giving it a more international character.

 

For more information on regulanet®,


Pricing, Reimbursement & Market Access:

  • Development Strateg
  • Dossiers of value
  • Health Economics and Outcomes Research
  • Risk sharing agreements

 

Selection of Experiences

  • Price and product strategies
  • Ellaboration of dossiers of value focused products and diseases with an economic approach
  • Studies of cost and minimizing costs, effectiveness, cost benefit, and cost utility
  • Pharmaceutical remodeling
  • Observational studies pre and post launch
  • Feasibility studies, development strategies, and implementation of Risk Sharing agreements

Experiences in Regulatory Affairs:

  • Regulatory support for a MRP registration procedure for a fixed dose combination of two generic drugs, including Modules 2-4-5
  • Several variations type II
  • Preparation of several CTAs
  • Application of a CEP at EDQM for a given API
  • Preparation of 3 technical files of medical devices class III and class IIa
  • Preparation of several Clinical Evaluation Reports for a medical device class IIb
  • Preparation of several regulatory strategic roadmaps for drugs, medical devices and food supplements
  • Several Scientific Advices at AEMPS, EMA and EFSA


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