International Drug Development

What International Drug Development does

International Drug Development (IDD) is a Paris-headquartered regulatory affairs and pharmaceutical development strategy consultancy founded in 2003 by Hélène Rouquette, a Doctor of Pharmacy with nearly 40 years of drug development experience. The firm delivers high-end consulting services across the pharmaceutical value chain through three integrated vertical lines: an Asset Pre-Approval Practice covering development and regulatory strategies, CMC, preclinical, and clinical support from Phase 1 through registration (EU CP/DCP/MRP/National and US FDA NDA/BLA); a Medicines Post-Approval Practice covering lifecycle management, variations, pharmacovigilance, and market access; and a Business Platform Services line providing client advisory and a commercial operating company platform.

The firm serves pharmaceutical and biotechnology clients of all sizes — from early-stage startups to long-established companies and public sector actors — across Europe (including UK and Switzerland) and the United States. Its go-to-market is relationship-driven, delivering custom-tailored professional service engagements ranging from concise one-shot projects to long-term strategic partnerships, with pricing positioned as competitive against larger traditional consultancies through lower overhead and faster turnaround.

In 2024 IDD expanded its model by creating Bio Valys Pharma (BVP), a wholly-owned subsidiary acting as an EU exploitation platform that hosts marketing authorizations, operates wholesale/operator infrastructure, manages pharmacovigilance, and supports distribution on behalf of third-party MA holders. BVP officially opened for commercial operations on January 1, 2026, launching its first product ESKESIA. The group has completed over 3,000 missions since 2003 and operates with a small, agile senior leadership team supplemented by interns and recent senior hires in regulatory affairs and pharmaceutical operations.

Name

International Drug Development

Legal name

International Drug Development (IDD)

Website

https://idd-sa.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

11–50 employees

Short description

International Drug Development is a Paris-based regulatory affairs and pharmaceutical development strategy consultancy founded in 2003, serving pharma and biotech clients across EU and US markets with end-to-end services from preclinical through commercialization, including a subsidiary commercialization platform.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Consulting

NAICS

Management Consulting Services (54161), Pharmaceutical Preparation Manufacturing (325412)

SIC

Services-Management Consulting Services (8742), Services-Health Services (8000)

akta.pro industry

PRIMARYHLAIALAH

Regulatory Strategy & IND/NDA/BLA Submissions Support

Healthcare & Life Sciences/Pharmaceuticals/Pharmaceutical Research and Development

SECONDARYHLAGAAAH

Pharmacovigilance, Risk Management & Medical Affairs CROs

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAHAM

Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/API & Small-Molecule Development/Manufacturing Services

Keywords

• Pharmaceutical regulatory consulting
• Drug development strategy
• Marketing authorization support
• Pharmacovigilance services
• CMC regulatory affairs

Headquarters

HQ city

Paris

HQ country

France

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Regulatory Affairs Consulting Services: IDD generates revenue through providing high-end consulting services across the pharmaceutical development and commercialization lifecycle. Services include development and regulatory strategies, project management, CMC support, preclinical and clinical assistance, regulatory dossier preparation and submission, lifecycle management, pharmacovigilance, quality compliance, and pharmaceutical establishment operations. Revenue is generated through professional service engagements, which may be one-time projects or long-term strategic partnerships.
2. Commercial Operating Platform (Bio Valys Pharma): Through its subsidiary Bio Valys Pharma, IDD operates a commercial pharmaceutical platform for marketing essential medicines. Bio Valys Pharma (BVP), established in 2024 and officially launched January 1, 2026, serves as a commercial operating company (exploitant) acting on behalf of third parties, hosting MA assets and supporting market access and commercialization operations.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels5 records

Core offering

IDD is a high-end consulting firm that provides tailored regulatory affairs and development strategy services to pharmaceutical and biotechnology sponsors across the drug value chain, from preclinical and CMC development through clinical trial design, marketing authorization dossier preparation and submission (EU CP/DCP/MRP/National and US-FDA NDA/BLA), lifecycle management, pharmacovigilance, and quality compliance. Through its wholly-owned subsidiary Bio Valys Pharma, the firm also operates as an EU commercial operating company (exploitant) that markets essential medicines such as ESKESIA on behalf of third-party MA holders.

Product overview

International Drug Development (IDD) is a high-end consulting firm specializing in regulatory affairs and development strategy for the pharmaceutical industry. The company provides three integrated vertical service lines: (1) Asset Pre-Approval Practice covering development & regulatory strategies and project management for preclinical, CMC, clinical, and regulatory phases; (2) Medicines Post-Approval Practice for regulatory affairs and lifecycle management; and (3) Business Platform Services including client advisory and commercial operating company services through its subsidiary Bio Valys Pharma. Bio Valys Pharma serves as an EU exploitation platform compliant with pharmaceutical standards, offering wholesale/operator infrastructure, pharmacovigilance activities, and distribution management for third-party MA holders. The group delivered ESKESIA® as its first marketed product in January 2026.

Differentiator

Problem solved

Functional benefit

Brands

• Bio Valys Pharma: EU exploitation platform compliant with pharmaceutical standards for commercializing essential medicines. Launched ESKESIA® drug in January 2026.

Products and services

• Asset Pre-Approval Practice Integrated scientific and strategic consulting and operational management for complex development projects, from preclinical (PK/PD, toxicology, impurity qualification) through CMC (drug substance and drug product) and clinical (trial synopsis design, CRO management), to regulatory dossier preparation and submission (EU CP, DCP, MRP, National, US-FDA NDA, BLA) and EU/FDA scientific advice. Targeted at pharmaceutical sponsors developing chemical or biologic medicines, including advanced therapies, from Phase 1 through registration.
• Medicines Post-Approval Practice Scientific and technical consulting dedicated to the preparation, submission, and negotiation of post-approval dossiers and lifecycle management activities, including health authority interactions, dossiers/product/portfolio audit, CMC/Quality/Module support, variation submissions and publishing, risk management plan, leaflet readability testing, early access program management, prescription status evolution, and market access.
• Business Platform Services Client advisory and commercial operating company services including 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), market access, HCP/HCO interaction compliance, crisis management, public affairs, regulatory compliance, inspection readiness, training, QMS creation, SOPs & ARS, sales representative charter certification, promotional material approval, and ready-to-use commercial exploitation via Bio Valys Pharma.
• ESKESIA Flagship essential medicine marketed by Bio Valys Pharma, the wholly-owned commercial operating subsidiary of IDD, launched commercially on January 1, 2026. ESKESIA is distributed via Bio Valys Pharma's EU exploitation platform on behalf of third-party MA holders.

Quantifiable outcome

• Successful Marketing Authorization obtained within targeted timeline for first-time DCP submission client
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

One partnership is on record.

• Bio Valys PharmacoreStrategic or Co-development Partner · 1 January 2024Bio Valys Pharma (BVP) is a subsidiary of International Drug Development (IDD), created in 2024 as an autonomous pharmaceutical platform for marketing essential medicines. BVP officially launched on January 1, 2026 with its medicine ESKESIA. BVP serves as a commercial operating company (exploitant) acting on behalf of third parties, providing EU exploitation platform compliant with pharmaceutical standards. BVP strengthens IDD's capabilities by adding a dedicated pharmaceutical exploitation and commercial platform to complement IDD's regulatory consulting expertise. The combined group offers end-to-end solutions from medicine development through commercialization. Led by a team with over 30 years of pharmaceutical industry experience.

Scale indicators5 records

Recent moves8 records

Expansion highlights6 records

Broad incumbents

• ICON plc: ICON plc is a major global CRO with regulatory and pharmacovigilance capabilities alongside its clinical operations core. It is a relevant incumbent competitor for IDD on regulatory mandates that sit inside larger integrated programs.
• Charles River Laboratories: Charles River Laboratories offers a broad suite of preclinical, CMC, and regulatory services to pharma and biotech. Its CMC and regulatory consulting practice overlaps with IDD's CMC and dossier support functions within a much larger discovery-to-manufacturing platform.
• IQVIA: IQVIA is the largest global CRO and life sciences services provider, with regulatory affairs embedded in its clinical and commercial offerings. It competes with IDD for regulatory engagements but addresses a much wider range of services at much greater scale.
• Parexel International: Parexel is one of the largest global CROs offering regulatory, clinical, and commercialization services across the full development lifecycle. It competes with IDD for regulatory affairs work but as part of a much broader portfolio that includes clinical operations and biopharma services.

Direct peers

• Camargo Pharmaceutical Services: Camargo Pharmaceutical Services specializes in 505(b)(2) regulatory pathways, ANDA, and NDA strategy and submissions. It is comparable to IDD in regulatory strategy and dossier preparation, though with a stronger US regulatory niche.
• ProPharma Group: ProPharma Group is a regulatory, compliance, and pharmacovigilance consultancy serving pharma, biotech, and medical device companies. Its service portfolio in regulatory affairs, quality compliance, and M&A due diligence overlaps closely with IDD's three practice lines.
• Voisin Consulting Life Sciences: Voisin Consulting Life Sciences is a European-headquartered regulatory and HTA consultancy supporting product development, registration, and market access. It is highly comparable to IDD in regulatory strategy and health authority interactions across EU and US.
• NDA Group: NDA Group is a regulatory affairs services firm providing MA application support, lifecycle management, and health authority interactions. Its boutique focus on regulatory and drug development strategy makes it a close structural peer to IDD.
• PharmaLex: PharmaLex (now part of Cencora) is one of the largest specialist regulatory affairs and pharmacovigilance consulting firms, serving pharma and biotech across development, submission, and post-approval. It is the most direct scaled peer to IDD in regulatory strategy, MA dossiers, and lifecycle management.
• BlueReg: BlueReg is a European regulatory consulting firm offering MA strategy, submission management, and pharmacovigilance services. Its geographic and service overlap with IDD's European-centric offering makes it a directly comparable boutique peer.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat4 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/international-drug-development

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about International Drug Development