We are a high-end consulting firm specialising in regulatory affairs and development strategy for the pharmaceutical industry.
Development, registration, commercialization: tailored excellence for your healthcare products. Our team of scientific and regulatory experts supports your strategic and operational challenges, from development to the commercialization of your healthcare products.
We are a high-end consultancy specializing in regulatory affairs and development strategy for the pharmaceutical industry. We provide customized services across the drug value chain, from early drug development through to commercialization.
Our expertise addresses all the challenges of the pharmaceutical industry across every market: we secure your projects at every stage of their development.
“At IDD, we don’t just adapt to change – we drive it. Our entrepreneurial spirit fuels our commitment to tackling your complex projects and delivering tailored, high-value solutions for the pharmaceutical industry.”
Hélène Rouquette, Founder and Chairman, IDD
We improve health through three core-integrated vertical services:
Asset pre-approval practice
Development & regulatory strategies / project management
Integrated scientific and strategic approach to complex development projects, CMC, preclinical, clinical, and regulatory: consulting, writing of regulatory documentation, operational management.
Cross-functional expertise federated as a project Team to support pharmaceutical Sponsors in the roadmap of their candidate medicine, either chemical or biologics, including advanced therapies , from early stage (Phase 1, FIH) to late stage (Phase 3/registration), and adapted to the clinical stage considered:
- Preclinical: assist in the design of pH/PD and toxicological studies ; impurity qualification strategies and viral assessment;
- CMC: support Drug Substance and Drug Product development: regulatory gap-analysis, integrated CMC activities management;
- Clinical: assist in the design of clinical trial synopsis; project management of CRO on behalf of the Sponsor
- Regulatory: to take advantage from regulatory interaction and/or acceleration pathways within EU/FDA in order to speed up and derisk development of medicine (e.g. EU/FDA scientific advice meetings, unmet medical needs incentives); to support clinical trial application and marketing authorization dossier constitution (EU CP, DCP, MRP, National, and US-FDA NDA, BLA) in compliance with regulatory constraints
External operational management of technical and scientific activities on behalf of our Client is one of the strengths that we have cultivated over the past decades. Our project Team manages activities from CMO/CRO identification, quality audit, protocol development study phase implementation/oversight
Medicines post-approval practice
Regulatory affairs and lifecycle management
Scientific and technical expertise dedicated to the preparation, submission, and negotiation of critical dossiers.
- Interactions with national and regional health authorities
- Dossiers/Product/Portfolio audit, CMC/Quality/Module, lifecycle management (variation submissions), publishing
- Risk management plan, leaflet readability testing, early access program management, prescription status evolution, market access
Business platform services
Pharmaceutical and regulatory expertise to support your commercial operations: market access, opening, and structuring of pharmaceutical operating establishments. Commercial operating company (exploitant) acting on behalf of third parties.
Client advisory
- Business and operator infrastructure set-up
- Ownership transfer, M&A extension, portfolio acquisitions and divestitures
- Due diligence on assets and dossiers
- Full pharmacovigilance activities, EUQPPV and deputy[SLE1] , market access and prescription status, HCP/HCOs interaction compliance, crisis management and public affairs
- Regulatory compliance, readiness inspections, training programs, G&P audits and third-party management, QMS creation and SOPs & ARS, sales representative charter certification, promotional material approval
Commercial operating company
- Ready-to-use commercial platform, wholesale/operator infrastructure, products and financial flow management
- Full pharmacovigilance activities, PR & EUQPPV and deputy registration, medical coverage and quality supervision, early-access schemes, sales representative and charter certification, promotional material approval
- Public tender management, complaints and batch monitoring, critical medicines and shortage minimization management
Regulatory Support Across the Product Lifecycle
We support pharmaceutical clients of every size and profile – from early-stage startups to long-established companies and institutional actors.
In a field where the rules are complex and the stakes are high, no two clients face the same challenges. Some are familiar with the regulatory landscape but need help with applying it to their products. Others need full-spectrum guidance from the ground up. From concise one-shot support to long-term strategic partnerships, we deliver tailored, reliable expertise – whatever your profile.
We are proud to embody this model that combines deep industry focus, extensive knowledge resources, faster turnaround times, and lower overhead costs. This approach allows us to offer highly competitive services, especially valued by private sector clients seeking more reasonably priced solutions amidst macroeconomic pressures. Our commitment to delivering exceptional value and efficiency is unwavering, ensuring our clients receive sur-mesure outcomes even in challenging economic climates.