Dr. Olga Kolcakova

Responsibility for assigned submission projects for customers. Coordination of compilation of dossiers in eCTD format – CMC, clinical and pre-clinical parts (Modules 2 – 5); Responsibility for compliance of the regulatory documentation with regulatory requirements. Management of submissions; Preparation of responses; Interaction with EU agencies; Product Life Cycle Management. New Marketing Authorisations, variations, renewals; DCP, MRP, NP; Training of junior employees.

Assessment of CTD Modules 2, 4 and 5 of the registration documentation (human drug products). New Marketing Authorisations, variations, renewals, repeat use – DCP, MRP, NP. Creation of assessment reports (RMS, NP) and comments (CMS). Member of Safety Working Party EMA (London) – representative of the Czech Republic.

Leading of a validation project during reconstruction of the Crawley manufacturing plant – small molecules. Close cooperation and negotiation with external companies and other departments within the organisation. Planning, coordination and execution of manufacturing equipment, facility and utility qualifications; Participation on new products launches. Creation, review and approval of relevant GMP documents. Risk Assessment of technical issues. Experience with MHRA and internal audits.

Leading of a validation project during complete reconstruction of two manufacturing plants. Leadership of multi-disciplinary teams; Close cooperation and negotiation with external companies and other departments within the organization. Planning, coordination and management of cleaning, process and product validations and manufacturing equipment, facility and utility qualifications. Risk Assessment of technical issues. Experience with FDA, SIDC and internal audits.

Coordination of new products and drug substances stability studies, follow-up stability studies – small molecules.