Experts across the board

Inits is a team of experts committed to delivering medicines that have a significant impact on patients’ lives.
We are specialized in drug development support and management, covering CMC (Chemistry, Manufacturing, and Controls), IMP (Investigational Medicinal Products), Regulatory, QA (Quality Assurance) and audits.

Operations

Regulatory

Clinical Supply

CMC

SMO

Amel

CEO and Founder

Amel has 23 years of experience in the pharmaceutical industry. She has held positions such as CDMO Site Director, Pharma Development Consultant, COO, Auditor of pharma and lab sites.

Amel

CEO and Founder

Amel has 23 years of experience in the pharmaceutical industry. She has held positions such as CDMO Site Director, Pharma Development Consultant, COO, Auditor of pharma and lab sites.

Setti

Chief Financial Officer

Setti has 8 years of experience in the pharmaceutical industry and she has held various administrative roles.

Setti

Chief Financial Officer

Setti has 8 years of experience in the pharmaceutical industry and she has held various administrative roles.

Marie-Christine

Project Assistant

Marie-Christine has 9 years of experience in the pharmaceutical industry. She has previously worked as a Project Assistant in a CDMO.

Marie-Christine

Project Assistant

Marie-Christine has 9 years of experience in the pharmaceutical industry. She has previously worked as a Project Assistant in a CDMO.

Nathalie

Adminstrative Assistant

Nathalie has 30 years of experience in administration and accounting in retailing. She has worked in several industries and is part of INITS since 2024.

Nathalie

Adminstrative Assistant

Nathalie has 30 years of experience in administration and accounting in retailing. She has worked in several industries and is part of INITS since 2024.

Mélanie

HR Manager

Mélanie has 12 years of experience in Human Resources, with a specialization in payroll. She previously worked in the medical industry and supports both employees and the company in their growth and development.

Mélanie

HR Manager

Christelle

Head of Strategic Partnerships and Business Development

Christelle has 20 years of experience in the pharmaceutical industry with a PhD in cell therapy. She has worked as a CMC project manager with a specialization in cell and gene therapy products.

Christelle

Head of Strategic Partnerships and Business Development

Christelle has 20 years of experience in the pharmaceutical industry with a PhD in cell therapy. She has worked as a CMC project manager with a specialization in cell and gene therapy products.

Tanguy

Business Development Officer

Tanguy has an engineer degree in biotechnology, supplemented by a Master's degree in Marketing and development of innovative health solutions.

Priscilla

Head of QA

Priscilla has 14 years of experience in the pharmaceutical industry. She worked in Quality Control as a technician, then in Quality Assurance as QA Manager and Project Leader. She joined INITS as a QA consultant specialized in QMS for biotechnologies.

Priscilla

Head of QA

Christophe

QA Consultant

Christophe has 20 years of experience in the pharmaceutical industry. He held different position such as Responsible Pharmacist, QP and QA specialist with QA position in France and abroad.

Christophe

QA Consultant

Christophe has 20 years of experience in the pharmaceutical industry. He held different position such as Responsible Pharmacist, QP and QA specialist with QA position in France and abroad.

Amandine

Quality Officer

Amandine has 6 years of experience in the pharmaceutical industry. She had several experiences in laboratory and energy, and joined INITS as Quality Officer.

Amandine

Quality Officer

Amandine has 6 years of experience in the pharmaceutical industry. She had several experiences in laboratory and energy, and joined INITS as Quality Officer.

Anais

Quality officer, intern

Anais has 2 years of experience in the pharmaceutical industry. She worked as a Quality Technician Assistant and joined INITS as a Quality Officer.

Anais

Quality officer, intern

Anais has 2 years of experience in the pharmaceutical industry. She worked as a Quality Technician Assistant and joined INITS as a Quality Officer.

Laurine

QA Consultant

Laurine is a chemical engineer and has a PhD in peptide chemistry applied to marine ecology. Her technical expertise focuses on peptide production, in which she worked for 2 years as a project manager. She then spent 2 years as Quality Manager for QMS implementation and management.

Maëlle

Quality Officer - EDM

Maëlle has engineering degree and has 3 years of experience in the pharmaceutical industry. She specializes in EDM and QMS. She has worked as a System Quality Assurance Officer apprentice at a veterinary pharmaceutical manufacturing site.

Margot

Head of Clinical Supply

Margot has 12 years of experience in the pharmaceutical industry. She had different positions such as Trial Supply Operation Manager and Lead of Clinical Supply Project Team.

Margot

Head of Clinical Supply

Margot has 12 years of experience in the pharmaceutical industry. She had different positions such as Trial Supply Operation Manager and Lead of Clinical Supply Project Team.

Caroline

Clinical Supply Manager & CMC Consultant

Caroline has 8 years of experience in the pharmaceutical industry. She worked as CMC and Clinical Supply Project Manager for CDMO and as consultant for a big pharma.

Gwendoline

Clinical Supply Manager

Gwendoline has 7 years of experience in the pharmaceutical industry. She worked as a Clinical Project Manager and Clinical Supply Project Manager.

Gwendoline

Clinical Supply Manager

Gwendoline has 7 years of experience in the pharmaceutical industry. She worked as a Clinical Project Manager and Clinical Supply Project Manager.

Stéphanie

Clinical Supply Manager

Stéphanie is a pharmacist with 13 years of experience in the pharmaceutical industry, specializing in clinical research. She had different positions such as Clinical Research Coordinator and Clinical Supply Chain Project Leader.

Laura

Head of CMC and Regulatory

Laura has 10 years of experience in the pharmaceutical industry. She worked as a CMC project manager in AAV process development, GMP production, analytical development and Director of technical operations.

Laura

Head of CMC and Regulatory

Cyrille

CMC - QA Consultant

Cyrille has 25 years of experience in the pharmaceutical development of new chemical entities, from discovery through clinical trials, including IND/IMPD and NDA submissions. Over the past 15 years, he has taken on quality management responsibilities for CDMOs, biotech firms, and medical device companies.

Virginie

CMC Consultant

Virginie has 20 years of experience in CMC, both in R&D and industrial operations. Specialized in process development, she has contributed to the development and improvement of innovative biological products, including vaccines, immunoglobulins, viral vectors, and cell therapy, at various stages of development.

Virginie

CMC Consultant

Yann

CMC Consultant

Yann has 7 years of experience in the pharmaceutical industry. He has a PhD in Immuno-Toxicology and worked as Analytical scientist in gene therapy vaccine development and Project Manager on therapeutic proteins development.

Yann

CMC Consultant

Anne

Technical Consultant (CMC, Regulatory)

Anne has 23 years of experience in the pharmaceutical industry. She has worked for several year as a laboratory technician in gene therapy, cell therapy and bioassays. She joined INITS as a CMC and Regulatory affairs technical consultant.

Anne

Technical Consultant (CMC, Regulatory)

Nadia

CMC and Regulatory Consultant

Nadia has 11 years of experience in pharmaceutical development. She has a PhD in Cellular and Molecular Biology and acquired CMC expertise with extensive experience in manufacturing process development, technology transfer and manufacturing of innovative medicines within highly regulated environments.

Ludivine

Head of DS Manufacturing and Project Management

Ludivine has 11 years of experience in the pharmaceutical industry. She has worked as a DSP engineer and CMC project manager with a specialization in gene therapy products.

Ludivine

Head of DS Manufacturing and Project Management

Ludivine has 11 years of experience in the pharmaceutical industry. She has worked as a DSP engineer and CMC project manager with a specialization in gene therapy products.

Joëlle

Process Manager USP

Joëlle has 8 years of experience in the pharmaceutical industry. She has an engineering degree in biotechnology and worked as a USP engineer with a specialization in gene therapy products.

Loïc

Process Manager DSP

Loic has 11 years of experience in pharmaceutical/biotech industries. He has an engineer degree in biotechnology and has previously worked as Production DSP manager and Bioprocess project leader.

Bastien

Head of DP Manufacturing, Supply and Maintenance

Bastien has 16 years of experience in the pharmaceutical industry. He has held different positions such as CDMO Director, Head of CMC project manager, CMC/CTS project manager, Clinical project leader.

Bastien

Head of DP Manufacturing, Supply and Maintenance

Thierry

Maintenance Manager

Thierry has 29 years of experience in the field of multi-technical maintenance. He began his career as a maintenance technician and progressed to contract manager, working with clients across various industrial and pharmaceutical sectors.

Thierry

Maintenance Manager

Arnaud

DP & FP Manager

Arnaud has 9 years of experience in the pharmaceutical industry working in cleanroom environments. He holds a Pharm D degree and a specialized master's degree in pharmaceutical production management. He has held positions as continuous improvement officer and a sterile production sector manager at international CDMOs.

Arnaud

DP & FP Manager

Christel

Logistics and Supply Manager

Christel has over 20 years of experience in industrial Supply Chain. She has held various positions such as Supply Chain Manager Europe, Transport and Logistics Manager, and Customer Service Manager in diverse sectors including health biotech, pharmaceutical industry, and industrial manufacturing.

Camille

Head of Quality

Camille has 10 years of experience in the pharmaceutical industry. She has a PharmD specialized in biotechnology and ATMP. She worked as production manager in a Cell Therapy Unit and in a CDMO.

Camille

Head of Quality

Camille has 10 years of experience in the pharmaceutical industry. She has a PharmD specialized in biotechnology and ATMP. She worked as production manager in a Cell Therapy Unit and in a CDMO.

Agnès

QC Manager

Agnès has a PhD and 25 years of experience in pharmaceutical industry. Her expertise is specialized in Bioproduction, in development and QC laboratory. She has previously worked as Quality Control manager.

Mathilde

Site QA Manager

Mathilde has 8 years of experience in the pharmaceutical industry. She had multiple positions such as Production coordinator, Night Process Manager, Deputy Qualified Person, Packaging Manager. She joined INITS as CMC and QA Consultant and Auditor.

Mathilde

Site QA Manager

Sophie

Qualification/Validation/Metrology officer

Sophie has 10 years of experience in the pharmaceutical industry. She specialized in qualification and validation activities within pharmaceutical manufacturing sites. She worked as Qualification/Validation Manager and Quality Assurance Manager.

Sophie

Qualification/Validation/Metrology officer

Julia

Quality system Officer

Julia has 6 years of experience in the pharmaceutical industry. She specialized in Quality Management System within veterinary pharmaceutical manufacturing site. She worked as System Quality Assurance officer and Operational Quality Assurance Manager.

Marine-Emilie

Quality system Officer

Marine-Emilie has a general engineering degree. She first worked for 2 years in Quality, Health, Safety and Environment for food-industry. Since, she has been working for 3 years in health products sector as Quality Assurance (product and system) and Regulatory Affairs officer.

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