Medical Device R&D
Development of medicines and food supplements;
Pharmacotechnical development and production support;
Assessment of technical feasibility of projects; Implementation of the R&D area;
Preparation of technical documentation for the R&D area;
QbD (Implementation of this Tool);
Pre-formulation studies;
Support for CRO choices for pharmaceutical equivalence, bioequivalence and bioexemption studies;
Assessment, review and preparation of bioexemption reports;
Stability studies, evaluation of results and preparation of protocols and reports;
Technical justifications, risk analysis and quality management system documents;
Assessment, review and preparation of process validation protocols and reports;
Review, evaluation and preparation of pharmacotechnical and analytical reports;
Technical and regulatory strategies for registration and post-registration of medicines and food supplements;
Assessment, review and preparation of registration dossiers;
Support for compliance with regulatory requirements;
Technical training;