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About us

ClinicPharma deals with registration of medicinal products, their reimbursement, registration of medical devices, diet supplements, and clinical studies of generic, as well as, original drugs in Poland and European Union. Our services have scientific background as all registration and reimbursement requirements are scientifically based. | more

Registration of variations

  • classification of variations (type I, type II)
  • preparation of necessary documnets (depending on variation)
  • expert reports for variations
  • revision of information materials (if necessary)
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Registration of diet supplements

  • finding market niche for new product
  • preparation of indications acc to binding regulations
  • anticipation of decision of authorities
  • preparation of new DS based on single or multiple constituents
  • preparation and evaluation of information materials
  • preparation and evaluation of advertisements
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Registration of original products

Registration of innovative medicinal products - full registration based on documents supplied by applicant (some of them could be prepared by ClinicPharma)

Registration of bio-similar products

Registration of bio-similar products - full registration based on documents supplied by applicant (some of them could be prepared by ClinicPharma)

Registration of a generics

  • generic medicinal product (bioequivalence based)
  • generic medicinal product, according to „well established use” procedure
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Reimbursement of medical technology products

Reimbursement of medicinal products, bio-similar products, and medical technology
  • choice of the strategy
  • evaluation of chances for success
  • preparation of health technology assessment (HTA)
  • appraisal of HTA
  • analysis of safety
  • reimbursement of bio-similars
| more

Clinical trials

  • therapeutic exploratory
  • therapeutic confirmatory
  • therapeutic use
  • bioequivalence
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References ClinicPharma

Our experience:

  • registration of 81 generics: Poland, 20 products; UK, 42 products; and German, 21 products
  • we have successfully applied for 400 variations during our 4-years long activity
  • we have published two papers regarding pharmacoeconomics