Drug product formulation
development with
the protection
of intellectual property
Learn more
Description
The project included developing an oral delayed-release capsule (enteric). An innovative approach to formulation development allowed for bioequivalence with the reference product to be achieved and for the generation of intellectual property, which was confirmed by granting three patents.
In combination with an adequate registration strategy, an advantage over competitive manufacturers of generic drugs was obtained in the form of market priority, exclusivity, and patent protection for the applied technological solutions.
Key points:
Patent landscape overview
Formulation & registration strategy
Lab-scale prototypes
Manufacturing process development
Registration dossier
Technology transfer
We are here to share our knowledge with you.
Call us: +48 000 000 000
Talk to our team about your project
Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.
View more selected projects
We have a broad experience in problem solving pharmaceutical problems for diverse companies.
Feasibility study for the use of 3D printing in the drug product manufacturing
Scope of work:
Project managementManaging the developmentof the drug substance routeof synthesis and manufacturingprocess for an innovative moleculein the preclinical phase
Scope of work:
Manufacturing troubleshootingModernisation of the formulation development laboratory and the pilot plant
Scope of work:
Manufacturing troubleshooting