Many companies have their own regulatory department or a specialist, who, when necessary, deals with regulatory issues. Very often, during periods of peak loading of the registration department or during implementation of company's marketing plans to launch new products in the Ukrainian market (expansion of product portfolios, purchase or sale of rights to market products, maternity leave, business trips or other staff changes, etc.), we perform the "back office" function, namely:
- we prepare "on a turn-key basis" the dossier submission for new registration, re-registration, introduction of changes;
- we provide temporary outstaffing;
- we develop and adapt specific parts of the dossier, for example, the QCM, instructions, layouts, RMP, ACO, etc.;
- we translate scientific, medical, technical and legal documents;
- we organize notarization and apostilization of documents;
- we make layouts, perform prepress check for compliance with the requirements of the current legislation, as well as organization of submission of layouts for registration in the Unified Automated Information System (UAIS) of the State Service of Ukraine on Medicines and Drugs Control (SMDC);
- we carry out partial or complete outsourcing of quality management functions for finished products, for example, we perform activities on recognition, prolongation or certification of the manufacturing site compliance with GMP requirements, maintaining the database and updating received certificates;
- we carry out partial or complete outsourcing of medicinal product safety management functions;
- we carry out verification and alignment of advertising and promotional materials;
- we provide legal services and consultations;
- we provide printing, copying and completing the dossier for submission to competent authorities;
- we perform patent search, registration of trademarks or inventions;
- we receive import permits from the Ministry of Health of Ukraine and conduct customs clearance of unregistered samples of medicinal products, standards and reagents for quality control testing.
- extensive experience in all types of regulatory procedures, quality management and safety;
- large coordinated team, which allows to scale cooperation in a short time;
- deep understanding of the requirements of international pharmaceutical companies, maximum convenience in cooperation;
- practical experience with extremely complex and specific types of medicinal products (biotechnological, narcotic, radiopharmaceutical) and Applications (complete independent dossier, hybrid medicinal products and biosimilar, well-established medicinal use, fixed combination).
We are open to cooperation and ready to participate in a tender. To start cooperation or get advice please call +38 044 364-33-55, +38 044 221-71-29, write a letter to email@example.com or come and meet us in our office.