Target Product Profile: Definition of your product’s key features to guide the creation of your industrial development roadmap.
From Academic Research to Patients: Advancing methods to ensure a smooth transition from academic work to the first industrial and regulatory data.
Regulatory Landscape: Build the interaction plan and strategy of communication with the EMA & FDA.
Nonclinical Development: Choose the right model for your evidence-based strategy.
Clinical Plan: The backbone of your development program.
CMC Accelerated Development: Help in achieving scale-up for your production method.
Access to Market: Identify the target population and potential price.
Small Molecules Option
Strategic help on sub-contractor interactions and technical challenges.
Biologics Option
New innovative processes exist to develop and bring small molecules onto the market, such as setting up clinical trials “in silico.” Let us coach you on the ever-evolving validation strategies for accelerated production methods.
ATMP Option
With our colleagues at VCLS – who worked hand in hand with the EMA to create the first regulatory guidance on ATMP in 2000 – we provide end-to-end solutions and targeted services including:
- regulatory strategy
- CMC/quality, nonclinical, and clinical development
- market access strategy
- post-approval regulatory life cycle management
DEDICATED TEAM
![Post thumbnail Carlo Chiavaroli, PhD](https://voisinconsulting.com/wp-content/uploads/2019/11/Carlo_Chiavaroli_VCLS_2018-300x300.jpg)
![Post thumbnail Mark Gauthier](https://voisinconsulting.com/wp-content/uploads/2019/11/Mark-Gauthier-300x300.jpg)
![Post thumbnail Valérie Arnaudinaud-Lignier, PhD](https://voisinconsulting.com/wp-content/uploads/2019/11/Valérie_Arnaudinaud-Lignier_VCLS_2018-300x300.jpg)
![Post thumbnail Lise Merlay Barbin PhD, Eng.](https://voisinconsulting.com/wp-content/uploads/2021/04/Lise_Merlay-Barbin_VCLS_2018-e1620142833808-289x300.jpg)
![Post thumbnail Zoran Simic, MD, MSc, FFPM, MRCPsych, IFAPA](https://voisinconsulting.com/wp-content/uploads/2022/04/Zoran-Simic-300x300.png)
![Post thumbnail Gabrielle Nayroles, M.Sc.](https://voisinconsulting.com/wp-content/uploads/2019/11/Gabrielle_Nayroles_VCLS_2018-300x300.jpg)
![Post thumbnail Decebal Bora, Pharm.D., MPH](https://voisinconsulting.com/wp-content/uploads/2020/03/Decebal-Bora.jpg)
![Post thumbnail Cécile F. Rousseau, PhD](https://voisinconsulting.com/wp-content/uploads/2019/11/Cécile_Rousseau_VCLS_2018-300x300.jpg)
![Post thumbnail Peri Aghadiuno, MBBS, MRCOG](https://voisinconsulting.com/wp-content/uploads/2021/12/268-neighborHOOD_Showcase-268-scaled-e1638358951110-300x300.jpg)
![Post thumbnail Michael Day, PhD](https://voisinconsulting.com/wp-content/uploads/2019/11/Mike_Day-300x296.jpg)
![Post thumbnail Emmanuelle Sabbah-Petrover, PhD](https://voisinconsulting.com/wp-content/uploads/2019/11/Emmanuelle_Sabbah-Petrover-_VCLS_2018.jpg)
![Lionel Mavoungou, PhD thumbnail](https://voisinconsulting.com/wp-content/uploads/2023/10/Lionel-Mavoungou.jpg)
Lionel Mavoungou, PhD
Associate Director, Chemistry, Manufacturing and Controls (CMC) & Advanced Therapy Medicinal Product (ATMP)
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