Services

MAXIMA Health Research can provide service and act as a consulting agent in the field of regulatory support in all CIS countries.

  • Completion of documents, required for product registration
  • Collecting and handling the dossier for the primary registration/renewal/inclusion of changes according to the legislative requirements
  • Support of all the stages and procesess of registration in the local agencies and authorities
  • Development, approval and implementation of various types of packaging and local labeling in the manufacturing process
  • Applications to patent authority, support for patent protection and protection of trade names at the different stages

Services

MAXIMA could provide service and act as your consulting agent in all CIS countries.

Pharmacovigilance

Pharmacovigilance - a field of science and practical activity, which is associated with the identification, assessment, understanding and prevention of adverse negative effects of drugs (or any other issue relevant to them). This trend is becoming increasingly relevant in the global pharmaceutical industry (with the implementation of relevant obligations and responsibilities of manufacturers of various products), which is associated with high biological activity of new drugs, sensitization of the population to biological and chemical agents, the irrational use of medicines and the use of substandard drugs, medical errors.

Our experts will help you in building a system of pharmacovigilance in accordance with applicable laws and internal regulations of your company and will provide the following services:

  • training and consultation for staff of the company (regulatory specialists of monitoring) on pharmacovigilance system, the rules of Good Clinical Practice - GCP, security issues in the field of pharmacology, principles and rules of reports of adverse events, dates, terminology, criteria for evaluating information;
  • processing of spontaneous reports of adverse events, including those occurring during pregnancy, the application of pharmaceutical products in accordance with local regulatory requirements and procedures of the company; 
  • development and preparation of periodic safety reports;
  • implementing periodic security reporting.

For manufacturing companies we can guarantee strict confidentiality in the handling of information and respect of the intellectual property rights.

If you are interested in our service
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