Regulatory and Strategic solutions
for healthcare products
from Preclinical to Commercialization
EMA’s Feedback after 2 years of PRIME Procedure
The PRIME Procedure is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of… Read more >
We share the same culture, we understand your concerns and issues, we support your innovations.
Since 2003, IDD has provided a wide range of regulatory support services and assistance with MA applications and medical device certifications. Today, IDD designs innovative strategic solutions and develops new skills and expertise in the promising fields of biotech, targeted therapies and combination products.
We are fully committed to the following values: listening to our clients, being reactive to their needs, honouring our commitments, transparency in cooperation. These values are key to the relationship of trust we are building with our partners.
Hélène Rouquette
President
IDD, A SOURCE OF IDEAS AT EVERY STAGE IN THE DEVELOPMENT PROCESS AND LIFECYCLE MANAGEMENT
IDD is a consulting firm specialized in Regulatory Affairs and Drug Development Strategy, focusing on two complementary areas of expertise:
DEVELOPMENT STRATEGY AND PROJECT MANAGEMENT
REGULATORY STRATEGY AND LIFECYCLE MANAGEMENT
With our project teams and our network of experts, we mobilize all our internal and external resources to support your projects at every stage of the development process from non-clinical and clinical development to Marketing Authorization submission and lifecycle management.
IDD EXPERTISE
Global Regulatory strategy from Preclinical to commercialization
Product development strategy and Project management
- Define target product profile
- Design CMC, non-clinical and clinical development plans
- Manage Development studies
- Organize Scientific Advice with regulators, Pre-IND meetings
- Conduct Registration procedure
Operational regulatory support and lifecycle management
- Due diligence and Audits of dossiers
- Management of variations / Product information
- Regulatory updates
- Pharmacovigilance
- Support quality management process (PQR, Regulatory monitoring…)
- Reimbursement strategy
Communication with the Authorities
- Facilitate relationships with regional and local Health Authorities (National, EMA, FDA, export…)
- Support registration procedure and follow-up commitments with the key Regulatory Agencies in EU/US/Export
- Organize regulatory advice for the development program and the regulatory strategy
- Market access (HTA…)
