| Drug form development support |
Preformulation and formulation developmentThanks to our experience in the area of drug form research, we can support you during preformulation studies and formulation development, through: • API Suppliers’ qualification • Research and description of substance pharmacokinetic and physicochemical properties • Choice of excipients and packaging materials leading to a stable formulation – compatibility study • Dissolution research at the product development stage – we can design compatibility studies, leading to a stable drug formulation, saving costs and time of the overall drug development process. Our experience in the development of biorelevant dissolution profile methods, with high predicting potency, may let you avoid a project failure during the Bioequivalence Clinical Trials. Dissolution methods for quality control purposes may also be developed and validated • Performing dissolution profiles in three standard media (low/medium/high pH) for drug products + analytical method validation • Verification of pharmacopoeial analytical methods, their validation and transfer (especially HPLC, UV/Vis, LC-MS and GC-MS) • Impurity profile characterization • Residual solvents analysis • Cleaning validation • Pharmaceutical development registration documentation preparation (CTD, ICH) Analytical chemistryWe perform pharmacopoeial methods verification, as well as development, validation and transfer of new methods in compliance with EMEA and FDA regulations and ICH guidelines. We have an extensive successful track record in the development and validation of analytical methods for Assay, Impurities, Optical Purity, Dissolution and Cleaning Validation. Besides, we have experience in performing and reporting stability studies and impurity profile determination, together with genotoxicity studies of the identified impurities. The range of analytical techniques and methods we offer, includes liquid and gas chromatography (HPLC, UPLC, GC with and without HeadSpace) with a variety of detectors (MS, MS/MS, UV-Vis, PDA, Corona CAD, FLD, FID, ECD). Also capillary electrophoresis, ICP-OES, ASA, ESA, UV-Vis, FT-IR, XRF, on-line SPE (Symbiosis), derivatization for better detection of analytes, classic and potentiometric titration are offered. The samples measured can be not only of pharmaceutical origin, but also environmental and biological samples. We also offer services concerning chiral chromatography method development and ion-pair chromatography. Having developed a package of analytical tools and an extensive experience, we can also support you during the process of evaluation of API Suppliers. Submission documentation/ Drug Master File preparationMarketing authorization by the regulatory Authorities requires preparation of a submission documentation containing relevant information regarding drug substances and drug products (CMC part of CTD format). The documentation is being prepared to give evidence, that the drug substance / drug product is suitable for its intended use and that the manufacturing process is well established and controlled. In the field of submission documentation preparation, we propose active substance manufacturer selection, validation of analytical methods, their application and the compilation of the Applicant Part DMF. Concerning the active substance / drug product, the following issues are taken into account, when compiling the Drug Master File:
We can deliver documentation for a process held by the client, providing that production process is well established and described in Master production instructions, specifications of raw materials, packaging material as well as of the final product are defined, in-process controls, sampling points and procedures are clearly defined, critical process steps are validated, equipment is qualified, analytical methods are validated, impurity profile is established, stability program is set up and first data are available as well as basic GMP requirements are fulfilled. We know the specificities of EU- and US-dossiers and have long term experience in preparing them. |