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Besides online and in-house training, our team of experts is also providing consulting sessions that help clients overcome challenges of pharmaceutical development in order to launch their innovative treatment solutions. Get in touch using the form below today and our team will answer your questions in any area of your product lifecycle.
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. Helge Neidhardt – CMC
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. Helge Neidhardt – CMC
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
Consulting Case Studies
Viral Safety for Biologics: A biopharma company attempting to launch a virus clearance of biosimilars study was unsure about their plans for extended Phase I/II study and unable to create Phase III/market study. Thanks to Symmetric’s support, the company developed and executed virus clearance study of 3 selected ATMPs in less than 6 months. Discussions and insights about viral clearance reporting to EMA & FDA, design and validation of scale-down models, worst-case parameters and critical process parameters set the team for success.
Patient Centricity Opportunities: An orphan-drugs focused pharmaceutical company was struggling to implement patient centricity into their clinical trials development. Symmetric helped the clinical research team apply patient-focused strategies, beyond standard clinical trials. Development of innovative PRO strategies helped this client reduce the usual clinical trial drop-out rate from 30% to just 5%.
Paediatric Clinical Trials: A biopharma company was aiming to launch its first paediatric clinical trial. Consulting sessions with one of our experts solved client’s most burning issues regarding protocol writing, clinical trial model selection and recruitment of paediatric patients.. Moreover, using our global networks, we helped the company cooperate with relevant patient advocacy groups. As a result, client was able to create 5 age-tailored information booklets explaining CTs’ aims and procedures.