Regulatory Affairs Services Provider in Belgium
In Belgium, the Federal Agency for Medicines and Health Products (FAMHP) oversees the regulation of drugs, biologicals, and medical devices. The FAMHP’s primary mission is to protect public health by ensuring the safety, quality, and efficacy of therapeutic medicines, both for human and veterinary use. This includes homeopathic medicines, herbal medicines, pharmacy-made and officinal preparations, health products like medical devices and accessories, as well as raw materials used to manufacture medicines.
As a European Union (EU) Member State, Belgium allows manufacturers to obtain market authorization through several regulatory pathways, including national, centralized, decentralized, and mutual recognition procedures. Once the initial marketing authorization is granted, the Marketing Authorization division manages product variations, renewals, parallel imports, queries, and acts as the primary contact for manufacturers. The guidelines and application requirements for different products can vary and require submission in English, Dutch, and/or French, which can pose challenges for foreign manufacturers.
Why choose DDReg as a Regulatory Affairs Service Provider in Belgium?
As a trusted Regulatory Affairs Services Provider in Belgium, DDReg offers comprehensive regulatory services to ensure timely and compliant market authorizations. DDReg helps clients navigate the complex regulatory drug approval process in Belgium, our team provides ongoing support and develops customized strategies throughout all regulatory phases. We stay up to date with the latest regulatory requirements in Belgium to facilitate high-quality submissions and efficient product launches.
With our FAMHP Regulatory Affairs Consulting expertise, DDReg ensures reliable safety measures, effective risk mitigation, and smooth regulatory filings. Our Regulatory Affairs Consulting Services in Belgium collaborate with experts to make product launches and regulatory filings seamless, ensuring timely market access.
Our Regulatory Consulting Services In Belgium Portfolio Covers
- FAMHP Regulatory Consulting
- Regulatory Strategies and Expert Insights
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF Consulting
- Marketing Authorization Holder Services
- eCTD Publishing and Submission Services
- Regulatory Labeling Services
Our Regulatory Affairs Consulting Services in Belgium portfolio covers:
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
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...
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...
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
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...
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
