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Regulatory Services in Belgium

Regulatory Compliance Experts in Belgium

In Belgium, the Federal Agency for Medicines and Health Products (FAMHP) regulates drugs, biologicals, and medical devices. The FAMHP’s mission is to protect public health by ensuring the safety, quality, and efficacy of therapeutic medicines for human and veterinary use, including homoeopathic medicines and herbal medicines, pharmacy-made and officinal preparations, and health products, such as medical devices and accessories, as well as raw materials used to manufacture medicines. As Belgium is a European Union (EU) Member State, manufacturers that wish to obtain market authorization in Belgium can do so via national, centralized, de-centralized, and mutual recognition procedures. After the first marketing authorization has been granted, the Marketing Authorization division handles all activities regarding product variations, renewals, parallel import, queries and provides a contact for manufacturers. Guidelines and application requirements for different products vary and require submission in English, Dutch, and/or French which can be challenging for foreign manufacturers to decipher.

As a leading global contender, DDReg’s regulatory services in Belgium provides ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.

Our Regulatory Consulting Services In Belgium Portfolio Covers

  • Regulatory Strategies and Expert Views
  • Regulatory Due Diligence
  • Gap Analysis and Remediation
  • New Product Authorizations
  • Post Approval Life Cycle Management
  • CMC Advisory
  • ICSR Processing and Submission
  • Risk Management
  • Aggregate Reports
  • Signal Management
  • QPPV Services
  • Bio Waiver Justifications
  • Clinical & Non-Clinical Experts Reports
  • IPR Support, including Worldwide Patent Status and Patent Reviews
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Call us on:+1 (302) 601-2755
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