Clinical Trails and Registration of drugs, clinical trials and medical devices
For all our customers, we offer the following services in the field of registration of pharmaceuticals, clinical trials of drugs and medical devices:
- Primary contact for negotiations with the State Institute for Drug Control (SIDC) for submission to the national procedure and help clients in assessing and addressing queries from SIDC
- Consultation in administration in the Czech Republic, a decentralized procedure (DCP) or Mutual Recognition Procedure (MRP), either for a position the Reference Member State (RMS) and participating countries (CMS)
- Assistance in preparing applications for new applications licensee both national and central (EU) form.
- Evaluating the appropriateness and accuracy of the registration documents submitted at SIDC
- Preparation, review and completion of text and graphics packaging materials for new products in Module 1.3
- Translations of registration of texts (SmPC - File of product information, PIL - Information for the patient, the internal and external packaging) into Czech
- Caring for an existing registration, including extensions, administration of these types of changes (type IA-IB, Type II), renewal, termination of registration and solving problems in meeting the requirements SUKL
- Submission of periodic safety update reports (PSURs) and bridging messages to SÚKL
- Communication with translations into English registration authority, including applications of administrative bodies
- Direct and regular contact and visits on behalf of SUKL and its customers, as part of a general process of registration and regulation
- Negotiations with the authorities regarding the pricing and reimbursement on behalf of
- Advice on changes in the law, including the implementing regulations for the Law on the drug.
- Advisories how to streamline the approval process for the submitted documentation