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
Our Regulatory Affairs Consulting Services in Germany portfolio covers:
01
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
02
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
03
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
04
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
05
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
06
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
07
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
08
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
09
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
10
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
