Company A (European multinational), Southern England, supported licence maintenance activities in UK and Ireland by submitting national and Mutual Recognition variations via the agency portals, followed up on agency queries and updated product labelling as needed.
Company B (UK client), prepared and signed critical Quality Overall Summary for sterile eye drop product.
Company C (UK client), assisted client in submitting abridged application via DCP for injectable product. Advised on data requirements and submission strategy, prepared and updated modules 1, 2 and 3 as necessary. Submitted application to RMS and CMS and coordinated responses to questions received on days 105 and 120 of the procedure.
Company D (major US multinational), Maidenhead, provided advice on content and timings Paediatric Investigation Plans and Scientific advice procedures. Ensured adherence to all Risk Management Plan commitments. Advised on strategy for a type 2 variation involving a new dosage schedule.
Company E (medium-sized US multinational), Cambridge, updated dossiers to support MRP filings and prepared variation packages
Company F (foreign-based generics company), Essex, set up UK regulatory affairs department from scratch; prepared and submitted EU marketing applications via the decentralised and mutual recognition procedures; advised management on filing strategies for source transfers
Company G (UK-based manufacturer specialising in injectables), Essex, advised management on departmental structure, prepared Clinical Overview and Summary to support a paediatric indication, advised on regulatory requirements for various new products
Company H (foreign-based generics company), from own office, provided Non-clinical and Clinical Overviews, surveyed competitor SPCs in various EU markets in order to establish appropriate filing strategies
Company I (medium-sized French company), from own office, provided Non-clinical and Clinical Overviews for new products and licence variations
Company J (major UK-based OTC company), from own office, provided Clinical Overview and Summary for major line extension
