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Fields of Services
Technical and Medical Document Translation Services
  • All modules (Module 1 to Module 5) of the registration files
  • Type variation documents
  • Material Safety Data Sheet (MSDS)
  • Standard Operating Procedures (SOP)
  • Articles and publications
  • Non-clinical and clinical study reports
All documents are prepared in accordance with the requirements of Turkish MOH in terms of content, format and page setup.
Regulatory Affairs
  • Preparation of technical files of drug products for registration purposes according to the requirements in the common technical documents (CTD) format of the Turkish Ministry of Health (Module 1 to Module 5).
  • Deficiency letter responses
  • Preparation of PIL in accordance with Turkish MOH.
  • Preparation of SPC in accordance with Turkish MOH.
  • Preparation of type variation documents
  • Licence renewal
  • Conversion of registration files from NTA to CTD
  • Preparation of technical files of drug products for registration purposes in EU ans US in accordance with relevant guidelines and directives
  • Import Licence Registration from Turkish Ministry of Agriculture and Rural Affairs for the products such as; dietary supplements, vitamin-mineral combinations, herbal extracts, proteins and sportive nutrients
Trademark Registration
  • Trademark registration for all kinds of products ie; drug products, dietary supplements, vitamin-mineral combinations, herbal extracts, proteins and sportive nutrients including application, process monitoring and finally getting registration
Consultancy Services
  • Document provision, planning, application, coordination and consultancy for all kind of products (drug products, dietary supplements, vitamin-mineral combinations, herbal extracts, proteins and sportive nutrients) intended to be registered ın Turkey, Europe and USA.
  • Preparing, implementing and consulting marketing plans/business strategies for the companies intended to launch their products in Turkish or US pharmaceutical market.
Private labelling
  • Through USPL in USA and Amol Pharmaceuticals in India, BO Farma develops and manufactures vitamins, mineral, combination supplements, herbal extracts, whey protein, sport supplements etc.
Business Development
  • Assisting in finding originator or generic product dosiers, manufacturers and API sources.
  • Seaching patent status for EU and USA.
Promotion
  • Designing and manufacturing custom promotion materials
  • Printing ve secondary packaging services
 
 
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