DS2DP — Drug Substance to Drug Product — is more than just a name: it reflects 25 years spent linking the active substances to the finished products, between science and regulation, between the laboratory and the patient.
Today, I make this experience available to pharmaceutical and biotech companies looking for an expert, responsive, and committed partner—one who understands both their technical and regulatory challenges to provide pragmatic support at every stage of development.
Founder
Olivier Raux
Senior Consultant in Analytical and Pharmaceutical Development, CMC, Regulatory and Industrial Support.
From laboratory to project
Olivier Raux has spent over 25 years at the heart of pharmaceutical development, including nearly 20 years within an FDA-approved pharmaceutical company, where he led analytical development and contributed CMC success group-wide.
His career path has taken him from the lab bench—performing molecular structural analysis via IR and NMR in research centers of major international corporations—to directing technical and quality control teams, and ultimately steering complex pharmaceutical development projects.
Expertise built on action, not theory
He has driven over 20 international analytical transfers, contributed to the registration of a dozen formulations across 5 continents, conducted supplier audits in China and India, participated in the design of analytical laboratories (QC and R&D), and supported Phase I to III clinical trials across their entire CMC scope.
Proactive Scientific and Regulatory Watch
Driven by the conviction that expertise is continuously cultivated, he pursues ongoing training well beyond his field experience.
Key Achievements
It illustrates our capacity to support complex projects within international and regulated environments.
Development and validation of analytical methods (GC, HPLC, UPLC)
20+multi-site analytical transfers All successfull /5 continents
Secured regulatory approvals through CTD dossiers and CMC oversight of clinical trials (IND, IMPD), including face-to-face meetings with regulatory authorities
Supported CEP and DMF approvals — accelerating European market access and securing supply chains, including supplier audits in China and India
Managed pharmaceutical development projects — sustaining market access for a ctritical drug through reformulation and qualification of a new API supplierI
Deployed 3 analytical laboratories and trained operators (Brazil, Russia, Spain)
Elevate stability programs into compliance, covering development, registration, and variations
Supervised external/CDMO studies: analytical methods, microbiology, photostability, dissolution, and packaging compatibility
Scientific and regulatory intelligence
Personal qualities dedicated to your success
Hands-on and international experience, professional ethics built on a relationship of honesty, and a time-tested capacity to adapt…
An approach that combines scientific rigor, operational vision, and pragmatism to drive project advancement.
Responsiveness: ability to respond quickly to technical and regulatory challenges
International expertise: multi-regional experience (FDA, EMA, Anvisa) with a global vision
Adaptability: flexibility in approaches and working environments
Transparency: clear and honest communication with all stakeholders
Cross-functional management: proven leadership in coordinating multidisciplinary teams
Patient-centricity: every decision guided by patient priority
