R&D Service Offers:

The range of our service

Analytical Laboratory

The range of our service includes:

  • Qualification of suppliers of active substances, assessment of compliance documentation for active substances (API)with the applicable guidelines.
  • Verification of analytical methods for API.
  • Development and validation of analytical method for API and drug product.
  • Preformulation study for drug product: morphology for API, solubility test for API, development of dissolution methods (discriminatory power)
  • Stability and photostability study for drug product.
  • Preparing the registration dossier- Module 3 in CTD format.

Developments, validation and verification of analytical methods are conducted in compliance with ICH guidelines as well as with EMA and FDA regulation

Analytical Laboratory

Analytical Laboratory

Development is carried out using high-end equipment, based on:

  • chromatographic methods: HPLC, UHPLC, GC with headspace,
  • spectroscopies techniques: IR, UV-VIS also LC-MS, and MS/MS in cooperation with external laboratory,
  • diffraction and microscopic methods: XRPD in cooperation with external laboratory, particle sized distribution, particle
  • morphology (Morphologi G3). Scanning electron microscopy (SEM) in cooperation with external laboratory.
  • dissolution and disintegration techniques.
  • inhalation techniques: for powder inhalation and aerosols: fine particle dose by Next Generation Impactor (NGI) delivered dose (DUSA), etc.
  • Thermal analysis: DSC
Technological Laboratory

Technological Laboratory

The range of our services includes:

  • Selection and assessment of raw materials form qualified or prequalified suppliers.
  • The development and manufacturing technologies — for medicinal products and dietary supplements in form of tablets. Film-coated tablets, hard capsules. Direct compression, fluid bed granulation, high shear mixing as well as dry granulation (roller compaction) are available at laboratory scale (up to 1-2 kg), large laboratory scale (up to 5kg)and pilot scale (in cooperation with external site).
  • Technological test — the full range of IPC and IC control for manufacturing trials
  • Modification of current/ old formulation – in order to reduce COGS, improve process effectiveness, technology troubleshooting (sticking, picking, of the tablets, incorrect dissolution profile, unstable formulation etc).
  • Packaging – material selection.
  • Tooling test – steel type/ coating selection proper maintenance assessment
  • Preparing the registration dossier – Module 3 in CTD format.