Consulting & Regulatory Strategy Development

• Regulatory Affairs and Project Management Input - development and review of strategies and its monitoring, interpretation of guidelines and report to management on status, opinions on regulatory requirements, organization and presentation at agency
• Strategy Development - drafting of overall regulatory strategy, compiling of a dossier showing the requirements and levels of submission, organization of and preparation for meetings with assessors, regulators and interested parties.

Documentation and Submission of Marketing Authorization Application Documentation - with a good understanding of the product and the process along with cumulative expertise and experience on documentation, excellent compiling and creation of required documentation. Submission - With a good understanding of the assessment process, analysis of possible questions and preparation a response package in advance. National Competent Authority Interactions Frequent interactions with regulators across different approval procedures like marketing authorization applications, orphan drug designation, variation and renewals. An extensive network of key agency contacts for both formal and informal queries. Familiarity with the core areas of interest and prevailing views of the agency.

Post-Approval Regulatory Activities

• Development of strategies for post-approval variations to the marketing authorisation:
  • changes to manufacturing facilities or the process
  • changes to product characteristics or presentation of the product
  • introduction of additional indications to the original marketing authorisation
  • extension of shelf-life
• Monitoring of post-approval commitments and responses to ongoing questions
• Organization of post-approval meetings with regulators to address future issues in product development
• Discussion of variation strategies and timing with regulatory authorities
• Compilation and submission of responses to ongoing commitments, and variation dossiers

Due Diligence

• Company mergers and acquisitions - regulatory status of company's portfolio, regulatory implications of product pipeline
• Feasibility studies - regulatory implications of alternative product production and process, multi-source products
• Product licensing - regulatory requirements and hurdles for marketing authorizations

Medical/Technical Literature Search & Analysis

• Clinical and pharmaceutical technology literature search and analysis - for clinical expert reports, additional indications, marketing support and developing new regulatory strategies

Regulatory Intelligence & Research

• Supply of continuous stream of information - on new regulatory developments, clarification and interpretations of guidelines and requirements, current and recent developments on local and EU legislation

Training and education

Translation