Exdra
EXDRA is a full service provider in the pharmaceutical and medical device sector, specializing in regulatory affairs, research & development, product registration, and lifecycle management. Founded in 2002, it offers customized solutions to accelerate product commercialization and supports clients with project planning, scientific advice, clinical trial applications, manufacturing, business development, marketing, and education. The company emphasizes process excellence, compliance, and human resource management, including interim management and training through its EXDRA Academy.
Industries
Nr. of Employees
small (1-50)
Services
Strategic advice and operational support for regulatory submissions, international registration strategy, dossier preparation and interactions with authorities.
Preparation of clinical trial applications and core clinical documents (IB, IMPD) and support for GCP/GMP compliance related to investigational products.
Support for GMDP compliance, preparation of DMF/ASMFs and coordination of Certificate of Suitability (CEP) activities and inspection readiness.
Development of pricing strategies, pharmacoeconomic models and preparation for health technology assessment processes.
Regulatory and dossier-focused due diligence for M&A, licensing and other transactions in pharma, biotech and medical device sectors.
Design of document processes and workflows and implementation support for software tools to streamline regulatory documentation and reduce administrative overhead.
Strategic advice and operational support for regulatory submissions, international registration strategy, dossier preparation and interactions with authorities.
Preparation of clinical trial applications and core clinical documents (IB, IMPD) and support for GCP/GMP compliance related to investigational products.
Support for GMDP compliance, preparation of DMF/ASMFs and coordination of Certificate of Suitability (CEP) activities and inspection readiness.
Development of pricing strategies, pharmacoeconomic models and preparation for health technology assessment processes.
Regulatory and dossier-focused due diligence for M&A, licensing and other transactions in pharma, biotech and medical device sectors.
Design of document processes and workflows and implementation support for software tools to streamline regulatory documentation and reduce administrative overhead.
Expertise Areas
- Regulatory strategy and submissions
- Clinical trial application and management
- GxP compliance and quality management
- Dossier preparation for active substances and excipients
Key Technologies
- GMP/GCP compliance frameworks
- DMF / ASMF / CEP dossier preparation
- Regulatory submission pathways (centralized, decentralized, MRP/DCP)
- Clinical trial documentation (IB, IMPD)