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.

Product information

For researching companies - manufacturers of original products we can guarantee strict data confidentiality and full respect of intellectual property rights, as well as full compliance with politics in the field of product information and local regulation requirements:

  • translation from English into Russian and Ukrainian (product information, Summary of Product Characteristics, instruction for medical usage, patient information leaflet);
  • back translation from Russian and Ukrainian to the original language;
  • preparation and updating of the product information;
  • scientific and clinical summaries for local regulatory submissions 

If you are interested in our service
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