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Regulatory Services in Germany

Regulatory Compliance Experts in Germany

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) regulates medicines and medical devices to ensure patients have timely access to safe, efficacious, and high-quality medicines in Germany. BfArMs primary responsibilities encompass the licensing and registration of products (including homeopathic medicines), recording & assessing their risks, and monitoring the legal aspects of narcotics. BfArM also look into the publication of medical coding systems within the healthcare sector. Research and development is also a critical part of BfArM’s responsibilities wherein it engages in scientific research to stay updated of ground-breaking discoveries in the field. BfArM also conducts its activities in collaboration with international stakeholders.

Its ‘European and International Affairs’ executive department proactively improves BfArM’s place and enhances information management within the European Union (EU) and globally. The European and International Affairs department represents BfArM at European and global levels in various EU bodies i.e., HMA, CHMP, and EMA’s working groups. It also represents BfArM in CMDh, PDCO, and COMP thereby strengthening international exchange of medicine related information. Navigating the German regulatory services landscape can present challenges to manufacturers that are looking to penetrate the market for the first time. As part of its global regulatory affairs portfolio, DDReg holds in-depth expertise to provide support in compliant and seamless product registration and lifecycle management in Germany.

As a leading player in regulatory consulting , DDReg’s regulatory services in Germany provide pharmaceutical companies with end-to-end solutions related to developing tailored regulatory strategies and comprehensive support throughout the product lifecycle. The regulatory service portfolio for Germany ensures efficient submissions and post-market lifecycle management. Trust DDReg as your go-to partner for expert regulatory services in Germany.

Our Regulatory Consulting Services in Germany Covers

  • Regulatory Strategies and Expert Views
  • Regulatory Due Diligence
  • Gap Analysis and Remediation
  • New Product Authorizations
  • Post Approval Life Cycle Management
  • CMC Advisory
  • API -DMF
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