Formulation Development
Executive Summary TCI Laboratories is a Poland-based contract research and pharmaceutical development partner specializing in formulation R&D, analytical problem-solving, and regulatory-ready documentation for medicinal products. Founded in 2000 as a spin-off from the University of Gdańsk, the company combines strong academic roots with applied development and troubleshooting expertise for the pharmaceutical sector and related industries, while maintaining collaboration with a university. Its service portfolio includes formulation development, deformulation (reverse engineering) of generic products, forced degradation and stability studies, analytical method development, validation, and transfer, as well as registration dossier preparation. The company works with pharmaceutical and related industry partners that require flexible, science-driven support in developing new products, improving existing formulations, addressing technical challenges, and preparing documentation for registra
Production & Service Departament
New Drug Formulation Development
TCI provides pharmaceutical formulation R&D across a broad range of dosage forms. Its development work includes compatibility and solubility studies, formulation design, assessment of discriminatory power, and manufacturing process development. This supports the creation of robust, manufacturable products with a clear and well-documented CMC foundation from early development onward.
Process development and manufacturing support
TCI supports the transition from laboratory-scale development to pilot and full-scale manufacturing. Its capabilities include process transfer and adaptation, production of solid, semisolid, and liquid dosage forms, and packaging operations such as blister packing and bottle filling. The company also offers process optimization, validation, troubleshooting, and scale-up support to help partners establish reliable production pathways.
Deformulation and reverse engineering
TCI offers deformulation services for generic products, helping partners better understand complex reference products and define practical development or bridging strategies. This capability is particularly valuable in generic product development and in projects involving difficult-to-reproduce performance characteristics where formulation and analytical expertise must be integrated.
Regulatory Documentation with an Explicit Module 3/CMC Focus
TCI supports registration dossier preparation, including verification of product classification, expert scientific assessment, review and completion of required documentation, dossier preparation, and submission to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The company has long-term experience in preparing complete CTD Module 3 (Quality/CMC) documentation.
Analytical development and problem-solving
TCI provides analytical services that support both routine quality requirements and complex investigative work. Its capabilities include analytical method development, validation, and transfer, as well as targeted troubleshooting related to product performance, impurities, and stability. The company also performs quality control testing in line with the European Pharmacopoeia, the United States Pharmacopeia, and in-house specifications for raw materials and finished products.
Stability studies and impurity investigations
The company conducts forced degradation and stability studies, including testing under ICH- and EMA-aligned conditions and photostability studies. TCI also supports impurity-related work through synthesis, isolation, identification, and qualification using techniques such as IR, NMR, and MS. These capabilities help partners strengthen product understanding, mitigate development risk, and support regulatory justification.
Regulatory documentation and dossier support
TCI supports dossier preparation and regulatory documentation, with publicly stated long-term experience in preparing complete CTD Module 3 (Quality/CMC) documentation. Its support includes scientific assessment, verification of document completeness, dossier preparation, and submission support. This makes TCI a valuable partner for companies seeking an integrated approach that links development work directly with registration requirements.
Dosage Forms and Technology Expertise
TCI develops and manufactures a wide range of dosage forms, including solids such as granules, powders, pellets, tablets, lozenges, and hard capsules; semisolids such as ointments and gels; and liquids including solutions, suspensions, syrups, and ear, oral, and nasal drops. Its technical platform includes wet and dry granulation, extrusion, spheronization, coating, and homogenization.
