Get expert guidance to navigate the complex landscape of QbD and regulatory standards for your process development and validation, ensuring CMC package readiness, first-time dossier acceptance and market approval.
We are proud to have trained over 5'000 scientists, 300 biotechnology compagnies, all over the globe.
"Mylène and Hervé provide outstanding services! They are remarkable Biologics Process consultants. I also took four of their Master Classes: Process Validation, CQA, Cell Bank Development, and Continuous Processing. These classes gave me a significant understanding of what and how things/studies must be done to create a complete package for successful BLA submission. They have a great deal of experience and can share their experiences when we seek reliable information that is not necessarily clearly stated in the guidance. Every large pharmaceutical company has a senior scientist/engineer with unsurpassed knowledge and experience who mentors the peer, but often, small companies do not have that luxury. For me, these people are mentors. Because of hearing their valuable experiences and practical advice, I feel confident in moving forward with multiple projects in the right direction." - Yumiko Kobayashi, Director, Technical Operations at AVEO Oncology -
"Mylène and Hervé provided knowledge-based guidance on developing a manufacturing process for a complex molecule. From the beginning, they brought a strong problem-solving attitude and struck the right balance by applying specific know-how precisely where it was needed while respecting our knowledge and experience. They helped us fully understand the data we were generating. We felt that our project was important to them and saw them as part of the team, rather than as consultants who share their views and then depart." - Matteo Costioli, VP Process Development at Polpharma Biologics -
We offer a complete suite of CMC services uniquely tailored to meet your specific needs.
We support you to develop the CMC package from pre-clinical to launch for your specific product (Drug Substance & Drug Product).
View the core competencies and all consulting services that we offer.
To empower your professionals, gain customized learning experience in the privacy of your company with our In-House Trainings.
View the learning portfolio we offer to support your development activities.
Discover this unique comprehensive guidance created to support your process development and validation.
View our handbooks serie and their tables of content.
Mentor your CMC leaders with a comprehensive training program specifically designed for them.
View the 7-month training program we offer to support CMC leaders.
We possess decades of hands-on experience from initial research to regulatory compliance and market release.
Hervé is an internationally recognized bioprocess expert with over 42 years of experience in the development, manufacture and validation of biotech processes. He is credited with 21 patents and has authored 69 scientific papers. Over his 35-year career at Merck-Serono, he served as Vice-President of the Process Development Department. Hervé's expertise spans all CMC aspects of biotechnological products for IND/CTA and BLA/MAA applications, leading to the approval of several BLA/MAA submissions. He has extensive experience in creating high-quality, compliant CMC regulatory documents and developing strategies for complex CMC challenges. Hervé has also played a crucial role in health authority interactions and inspections at company sites.
Mylène brings 25 years of extensive experience in the biotechnology industry, having worked with renowned companies such as BiogenIdec, Sanofi, and Merck-Serono. She has demonstrated exceptional leadership in CMC, contributing directly to multiple clinical and commercial drug substance and drug product manufacturing facilities in both technical and management roles. Prior to transitioning to consultancy, Mylène led a multi-disciplinary CMC team to successfully achieve commercial approval for a biosimilar. Her expertise encompasses process development and validation, innovative technologies, process technology transfer and scale-up, manufacturing operations and investigations, CRO/CMO management, continuous improvement, regulatory requirements, and product launches.