Helping clients develop cutting-edge new drugs for the worldwide market. Applying latest trends in bioequivalence and dissolution testing to speed up research & development initiatives.
Dr. Paula Muniz – Bioequivalence, IVIVC
Dr. Klaus Rensing – ATMPs
Franz Nothelfer – Viral Safety
Dr. Malcolm Ross – Dissolution
Ensuring compliance of quality management systems through-out all phases of drug development.
Dr. Tony Cundel – Stability, Microbial Testing – Biologics
Dr. Malcolm Ross – Stability, Shelf-life – Solid Dosage
Helping companies successfully scale-up manufacturing of biologics, solid dosage forms, injectables and medical devices. Applying best practices in validation and technology transfer to our customer’s current goals.
Dr. Michael Braun – Solid Dosage
Dr. Samuel Denby – Biologics
Dr. Laura Butafoco – Injectables
Jan Harmsen – Industrial processes
Navigating clients through the complex regulatory landscape of pharmaceuticals and biologics. Co-creating and co-analysing clinical trials while focusing on fast-to-patient market access strategy.
Dr. Karl-Heinz Huemer – Paediatric Clinical Trials
Dr. Simon Day – Orphan Drugs Clinical Trials
David Schwicker – Orphan Drugs Market Access
Dr. Malcolm Ross – Value Added Medicines
Helping clients develop and launch new orphan drugs while staying compliant with the current regulations. Using our orphan drugs market know-how, from both EMA/FDA and industry perspective, to benefit from growing possibilities in rare diseases.
David Schwicker – Clinical Development, Regulatory, Market Access and Patient Centricity
Dr. Simon Day – Orphan Drugs Clinical Trials, Biostatistics
