Koteze, Sokola 1 st., 83-200 Starogard Gdanski, Poland
Phone/Fax: (+48) 58 531 02 59
Phone: (+48) 606 93 82 51

Pharmaceutical product development & CMC


  • Preparation and compilation of the registration dossier for medicinal product (pharmaceutical product development; planning experiments and tests; data collection and evaluation)
  • Up-grade of the registration dossier for medicinal product (evaluation of the up-to-date registration documentation; identification and analysis of deficiencies (gap analysis); preparation of an action plan including implications, alternatives and solutions the most favourable for the client and at the same time meeting requirements of Authorities/ Agencies, i.e. implementing post approval changes; the change of manufacturer/ supplier of API (Active Pharmaceutical Ingredient); addition of alternative supplier of API; introducing farmacopoeial methods; introducing additional methods on the external client request; evaluation and comparison of farmacopoeial vs. IH (In-house) methods; introducing new, additional requirements in connection with the changes of guidelines, monographs or customer request; checking for compliance with actual monographs (API, product, excipients, packaging materials))
  • Preparation and/ or coordination in preparation of experts’ reports
  • Coordination of contact maintenance and correspondence with Authorities/ Agencies (i.e. assessment and addressing the comments on registration dossier; preparation and compilation of responses to deficiency letter)
  • Quality assessment of DMF (Drug Master File)/ ASMF (Active Substance Master File)
  • Coordination and technical correspondence with manufacturers of API and/ or medicinal product
  • Development, implementation, validation, verification and transfer of analytical methods
  • Technology transfer
  • Analysis and interpretation of test results (i.e. assay, impurity profiles, dissolution profiles, stability studies, validations, transfers)
  • Development of quality specifications for raw materials, semi-finished products, products in-bulk, finished products, packaging materials
  • Preparation of plans and reports (i.e. analytical methods validation, stability studies, transfers)
  • Preparation of testing protocols for different types of analytical methods (i.e. content determination, purity test, dissolution test, dissolution profiles, content uniformity)


In a frame of tailored made services we prepare documentation as i.e. testing protocols or analytical methods validation plans which are totally tailored to requirements and needs of our customers (general or detailed). It should be noted that a very high level of detail in created documentation is mainly dedicated to Quality Control Laboratories operated in pharmaceutical companies and especially to these, which do not have their own R&D Center/ Laboratory. We are aware, that a work in Quality Control Laboratory is special. The most important element is the time running and effectiveness of test execution. Well prepared test protocol simplifies your job and gives you the benefit in the form of significant time saving.

Analysts can execute more analytical tests and supervisors can more effectively organize and control the Laboratory activity and finally they increase performance of the entire Laboratory. Preparation of even such complicated documentation as analytical methods validation documentation become easy and can be realized by technically efficient personnel of the Analytical Laboratory. The only thing is to execute analytical procedures described in detail, then fill in the protocols with the results obtained and enclose generated printouts. The protocols completed become the reports of analytical methods validation.


In each case, when the service you require is not listed on our website, please Contact us through contact form or by phone, and we will make every efforts to find the satisfactory solution for you.