European Authorities (EU)

We provide regulatory services to help pharmaceutical, biotechnology, and medical device companies achieve successful product approvals and maintain compliance across the European Union (EU). Our expertise covers centralized and national procedures, ensuring alignment with the European Medicines Agency (EMA) and local Health Authorities.

European Authorities (EU) – Overview

The European regulatory framework ensures the safety, efficacy, and quality of medicinal products across all EU Member States. The European Medicines Agency (EMA) coordinates centralized assessments, while national competent authorities oversee country-specific procedures. Together, they provide a harmonized approach to marketing authorization, clinical trial approval, and lifecycle management of pharmaceuticals.

Services

Active Substance Master File (ASMF)

Comprehensive documentation supporting the quality and manufacturing details of the active substance, submitted to ensure consistency and confidentiality in regulatory filings.

Ensures confidentiality of proprietary information while maintaining transparency with regulators.
Supports consistent active substance quality across multiple applications.

Centralized Procedure (CP)

Single EU-wide marketing authorization granted by the European Commission, valid across all Member States for innovative or biotechnological products.

Enables a single EU-wide marketing authorization through EMA.
- Ideal for innovative, biotechnology-based, or orphan medicinal products.

Certification of Suitability (CEP)

Confirms that the active substance complies with the European Pharmacopoeia monograph requirements, simplifying ASMF submissions and approvals across Europe.

Confirms compliance of active substances with European Pharmacopoeia standards.
Simplifies submissions by eliminating the need for detailed ASMF in each application.

Decentralized Procedure (DCP)

Used when a product is not yet authorized in the EU, allowing simultaneous approval in multiple Member States with one Reference Member State leading the assessment.

Allows simultaneous product approval in multiple EU countries for new products.
One Reference Member State leads the assessment to ensure harmonization.

EU Marketing Authorization Application (MAA)

Comprehensive dossier submission to obtain approval to market a medicinal product across the EU under CP, DCP, MRP, or NP routes.

Comprehensive dossier submission for product approval under CP, DCP, MRP, or NP.
Ensures compliance with EU regulatory and technical requirements.

Investigational Medicinal Product Dossier (IMPD)

Provides detailed information on the quality, manufacture, and safety of investigational products required for clinical trial authorization in the EU.

Provides detailed information on investigational product quality, manufacturing, and safety.
Required for clinical trial approval in EU Member States.

Mutual Recognition Procedure (MRP)

Facilitates recognition of an existing marketing authorization from one EU Member State by others, streamlining expansion across regions.

Recognizes marketing authorization from one EU country in others.
Streamlines market expansion across additional Member States.

National Procedure (NP)

Used for marketing authorization in a single EU Member State, typically for products with a local market focus or when other procedures are not applicable.

Used for product approval in a single EU Member State.
Suitable for locally marketed products or early-stage authorizations.

Lifecycle Management

–

Regulatory Strategy Consulting Services

–

eCTD Publishing and Submission

–

Clinical Trial Application (CTA) Support

–

EU Clinical Trial Regulation (CTR) submissions

–