Exspertize » Areas of expertise » Medical unit

Medical unit

Aston Group’s team of professionals in the field of HTA, biostatistics, IT, epidemiology, etc. offers a wide range of solutions based on a thorough market experience and collaboration with the medical community.

Preparing registration application/dossier and drug registration 

The smooth and prompt registration directly impacts the product launch, as well as achieving the sales and profit targets and the overall brand performance.

Aston Group provides comprehensive support for a new product launch and market entry:

  • Preparing registration dossier
  • Preparing application for new therapeutic indications
  • Building up pharmacoeconomic data to secure reimbursement
  • Putting together evidence to include the product in the negative drug lists
  • Filing certificate to confirm production pursuant to GMP

Preparing documents to approve GMP manufacturing conditions based on the inspection of the production site:

  1. Application for GMP Compliance Certificate
  2. Product evaluation for conformance with quality requirements
  3. List of products manufactured on the site being inspected
  4. A letter of consent for inspection from manufacturer
  5. GMP site file

Pharmacovigilance programs

Pharmacovigilance is monitoring of use of medicinal products in everyday clinical practice to identify previously unidentified adverse reactions or a change in the nature of adverse reactions. Under Russian healthcare laws, the information about adverse events (drug safety reports) should be reported on a regular basis by pharmaceutical companies or their authorized representatives to the Federal Service for Surveillance in Healthcare. In addition, when submitting a registration dossier, an applicant is supposed to present a Risk Management Plan, which is a detailed outline of pharmacovigilance measures to identify, assess, prevent or minimize the risks associated with the drug use. Particular attention is given to unwanted immunogenicity associated with the use of biological (immunobiological) products. These types of drugs require long-term monitoring as part of pharmacovigilance programs.

 

Developing market access strategy

In the recent years the pharmaceutical market has undergone some major changes, especially with respect to regulations and funding. These changes had an impact on market access strategies of many industry players. In the same manner, the ever-growing importance of payers changes the approaches to pricing and market access: health technology assessment now plays a crucial role in the launch of the novel pharmaceuticals.

New realities urge the drug manufacturers to tailor their strategies to the specifics of each region and territory.  This, in turn, requires in-depth market expertise of the local environment, including regulatory and financial aspects and establishing effective communication with local health authorities.

Aston Group with its resources and expertise helps customers to design and review their market access and pricing strategies through:

 

 

Marketing and sales

Strategical planning

Market access

CJSC Aston Consulting, 1999-2017