Regulatory and Strategic solutions

for healthcare products

from Preclinical to Commercialization

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.

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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…)