Regulatory Affairs

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

BIG PHARMA&MED SOLUTIONS
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