PRI - Pharmaceutical Research Institute in Warsaw, Poland, offers a comprehensive technology development and commercialization of medicinal products (API synthesis, drug dosage form, analytical services, registration). Research and development activities of Pharmaceutical Research Institute concern both generic and original, innovative drugs. PRI cooperates with pharmaceutical companies as well as scientific institutions. The research and development files are prepared according to the current regulatory requirements (GMP, GLP).

0.2 MB Offer of Pharmaceutical Research Institute

Our research and development offer:

• Chemical synthesis: literature survey, development of technologies in a laboratory as well as multigram scale, optimization of particular synthesis steps, preparation of the samples of pharmaceutical purity.
• Active pharmaceutical ingredient (API) manufacturing technology: process planning, development of technology (including the synthesis of new polymorphic forms), technology implementation.
• Analytics of active pharmaceutical ingredient (API) and drug form: certification, development and validation of analytical methods, impurity profiles, physico-chemical research, structural research, polymorphism of active pharmaceutical ingredients (included in the drug form), stability studies, pharmaceutical availability studies.
• Drug form technology: development of drug dosage form technologies at laboratory and ¼-plant scale, troubleshooting assistance at each stage of technology development, ongoing technology modification.
• Bioavailability and bioequivalence studies: study plan, development and validation of the analytical method, pharmacokinetic parameters calculation, statistical analysis.

Manufacturing offer:

• Active pharmaceutical ingredients (APIs) manufacturing in laboratory, kilolab and plant scale.
• Contract manufacturing of oral dosage forms in laboratory and ¼-plant scale during technology development modifications.
• Medicinal products manufacturing: soft capsules, oral drops, dry substances for solution preparation.

Other services:

• Patent surveys in chemistry and pharmacy: API synthesis, polymorphism and pharmaceutical dosage forms.
• Registration of medicinal products: preparation and evaluation of the registration documentation, organization of the registration and reregistration processes, post-registration changes, coordination of the information documents and expert reports preparation.

Please feel invited to enter into a successful cooperation with our company