Services
E&B Pharm Concilium supports pharmaceutical companies in their development and regulatory strategy decisions. Our expertise covers chemical and pharmaceutical development, regulatory strategy, clinical development and technical due diligence, with an integrated approach across all areas of development including CMC, quality, clinical and regulatory.
A global view of your development challenges
From drug substance development to market launch, we provide a tailored, highly technical response at every stage of your product development lifecycle. Our multidisciplinary expertise turns regulatory complexity into a secure, well‑controlled growth driver.
Chemical Development
We support the development and optimisation of your processes challenging the technical choices to reduce industrial risk and prepare a coherent and compliant CMC package.
- Process development and optimisation (DS and DP)
- Scale‑up to industrial scale
- Process validation (DS and DP)
- Technology transfer to a new manufacturing site
- Identification and qualification of external partners (CMOs, CDMOs, specialised analytical laboratories, etc.)
Pharmaceutical Development
We propose, manage and conduct your pharmaceutical development programs by integrating all CMC, quality, non‑clinical and clinical aspects, in order to structure projects that are well‑controlled, pragmatic and aligned with regulatory requirements.
- CMC
- Quality
- Regulatory Affairs
- Pharmacology and toxicology
- Clinical development (First in man and Dose-ranging studies)
- Optimisation of development plans​
Regulatory Strategy
We design and implement regulatory strategies tailored to your objectives, from the structuring of MA dossiers to territorial extensions, in order to optimise timelines and secure your approvals.
- Global regulatory development plan
- Preparation of MA, IMPD and scientific advice dossier
- Regulatory Authorities interactions and negociations
- Geographical extension strategy
Technical Due Diligence
We perform critical reviews of existing CMC, development (R&D, non‑clinical and clinical) and regulatory dossiers to provide an objective view of the asset's value and support your investment or partnership decisions, by highlighting risks and potential areas for improvement.
-
Critical review of CMC and development data
-
Identification of regulatory and technical risks (and improvement opportunities)
-
Decision-support summary with recommendations