Lifecycle Management

Geographical and Line extensions: Make authorisation in other EU markets possible using in-house and outside data and innovative regulatory strategies.

Regulatory defence strategies: What are the crucial areas to be addressed to keep the cash-cow products on the market for a few more years? Identify the critical issues in old dossiers and develop action plans to place them on a secure regulatory footing.

Dossier compilation, revision: Do you have some or all of the data but need to organise it into a dossier for submission? Do you need to incorporate approved variations into an established dossier? ASSENTRA can provide the expertise and extra resource to get it done on time.

Critical summaries and expert statements: Independent detailed and critical summaries (DACS) and expert statements prepared on vaccines and pharmaceutical products, from existing data and/or published literature for Part 3 Safety and Part 4 Efficacy dossier sections.

Planning, managing procedures: ASSENTRA can supplement your in-house resources and assist in planning and managing regulatory procedures at National or European (MRP/DCP, CP) level.

Marketing support: Marketing and business colleagues always need your advice or signature on packaging or promotional material TODAY! ASSENTRA can provide a compliance review and advice service against approved product literature, industry (NOAH) codes and legislation, while you concentrate on the approaching authority deadline. ASSENTRA advises; the final decision is yours.