Regulatory Affairs Service
JSC Corpus Medica supports pharmaceutical companies and provides Regulatory Affairs services. We are able to offer the following services to our clients within the European Union, US, Canada and third countries. The pharmaceutical companies, that this service has been provided to are:
- IVAX Pharmaceuticals s.r.o., Czech Republic/UK;
- Ranbaxy (UK) Ltd., Lithuania/UK;
- Sopharma Pharmaceuticals P.L.C., Bulgaria;
- Natur Product Europe B.V., The Netherlands;
- Concern Stirol S.C., Ukraine;
- Pharmstandard L.L.C. (former ICN – Leksredstva), Russia;
- Salts Healthcare Ltd., UK;
- Genericon Pharma Gesellschaft m.b.H., Austria.
Our services:
- Carrying out of the full registration process of a medicinal products in the Lithuanian Drug Registration Agency (DRA); obtaining of marketing authorization
- Application of medical devices to the Register of Medical Devices
- Registration/renew of Food Supplement, Herbal products, Special Medical Purposes products
- Notification of food supplements and cosmetics in appropriate Lithuanian Agencies
- Realization of some parts of the registration process
- Prolongation of marketing authorizations
- Preparation, translation and adjustment of Patient Information Leaflets (PIL), SmPC (Summary of Product Characteristics), mock-ups to the requirements of the Lithuanian DRA
- User Testing (Readability Testing) of PIL; preparation, testing, translation and report submission
- Transfer of marketing authorization
- Variations - submission and monitoring
- Generation of expert reports on Quality, Non-Clinical and Clinical documentation
- Pharmacovigilance service
- Generation of expert reports on clinical trial and pharmacoeconomics, applying for reimbursement in Lithuania
- Consultancy in Regulatory Affairs, collectiong information, consulting on completion of registration dossier, preliminary assessment of file, local language (or Baltic) pack development, registration procedure follow-up, corrections of PIL, SmPC, etc.
- Other
