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P H A R M A P L A N T

R&D

R&D

Pharma Plant has undertaken over 100 R&D projects to date, working with the aim of developing effective, safe, and innovative products that ensure patient compliance and empower patients to lead healthier, better lives across the globe.

Pharma Plant is dedicated to developing innovative products, achieving bioequivalence studies with high success rates, and preparing CTD for Turkey and other countries through its comprehensive R&D efforts. Pharma Plant Pharmaceuticals’ R&D laboratory continues to contribute added value to the Turkish pharmaceutical industry.

Within our R&D laboratory, a wide range of activities is carried out, including patent scanning and evaluation, active ingredient analysis and approval, formulation and analytical method development, process and analytical method validation, product improvement studies, new product stability assessments, and the preparation of registration files in CTD format, all done under the framework of Quality by Design (QbD).

Pre-Formulation

  • Characterization of original product and active substance
  • Compatibility studies of the active substance with excipients
  • Risk assessment.

Lab. Scale Studies

  • Process selection
  • Laboratory scale manufacturing process development
  • Final formula approval
  • Stability tests

Pilot Scale Studies

  • Scale-up production
  • Development of the pilot scale production process
  • Pilot series trial production
  • Pilot series production
  • Pilot series stability studies

Bioequivalence

  • Compatibility studies of the active substance with excipients
  • Risk assessment

Licensing

  • Preparation of files for presentation to the authority
  • Follow-up of the application to the health authority and the authority review and evaluation process
  • Compatibility studies of the active substance with excipients

Supply chain

  • Determining the appropriate supplier
  • Selection of the most efficient and economical means of transportation
  • Import process management
  • Customs process management
  • On time delivery