Bringing expertise and agility to

biotech companies

Our Company

INITS is a dynamic consultancy firm driven by quality and innovation. Assisting biotech companies to deliver medicines that have a significant impact on patients’ lives is our commitment.

Bringing expertise and agility to

biotech companies

Our Company

INITS is a dynamic consultancy firm driven by quality and innovation. Assisting biotech companies to deliver medicines that have a significant impact on patients’ lives is our commitment.

Bringing expertise and agility to

biotech companies

Our Company

INITS is a dynamic consultancy firm driven by quality and innovation. Assisting biotech companies to deliver medicines that have a significant impact on patients’ lives is our commitment.

Our Services

CONSULTING

We provide either a focused expertise or a comprehensive support across the entire pharmaceutical value chain

Discover more ->

SMO (Shared Manufacturing Organization)

We offer a dedicated bioproduction unit for preclinical and clinical trials, supported by a unique infrastructure and an experienced team

Discover more ->

CONSULTING

We provide either a focused expertise or a comprehensive support across the entire pharmaceutical value chain

Discover more ->

SMO (Shared Manufacturing Organization)

We offer a dedicated bioproduction unit for preclinical and clinical trials, supported by a unique infrastructure and an experienced team

Discover more ->

CONSULTING

We provide either a focused expertise or a comprehensive support across the entire pharmaceutical value chain

Discover more ->

SMO (Shared Manufacturing Organization)

We offer a dedicated bioproduction unit for preclinical and clinical trials, supported by a unique infrastructure and an experienced team

Discover more ->

250+

International clients

300+

Audits

50+

IMPD/IND
writing review

100+

QMS developped
& managed

50+

CMC projects managed

What our clients say

« INITS supported us in our first request for a scientific opinion from the EMA to validate our CMC strategy. We were extremely satisfied with the collaborative approach to regulatory dossier preparation, submission and interaction with the regulatory authorities. Many thanks to INITS for their professionalism and responsiveness. We're already planning what's next with the brilliant Inits team! »
Jeanne VOLATRON, CEO of EVerZom
« I would like to express my sincere recommendation about Inits as a professional consulting and supporting partner. Inits’ highly skilled team supported our vision, focusing on our requirements, and entirely completed each task in the expected timing. Inits team was contracted for supporting the CMC development of several programs. Our requests ranged from specific advice on the development of manufacturing process and analytical characterization and quality controls, to support writing documentation dedicated to regulatory scientific advice. Each time, the well experimented Inits team brought its experience, the last trends and regulatory bodies expectations. They provided appropriate recommendations to support the development of compliant product and consistent advice to address technical issues. The added values of Inits are its rapid responsiveness, their precise and well-founded answers, the fairness and honesty of their answers, a very good listening and friendly exchanges. Inits also provided a very complete GMP compliance training to most of the Coave Therapeutics team. In addition to the highly professional content, the pleasant atmosphere of the training eased the team learning. »
Nicole BRUMENT, VP CMC & Supply Chain
« Working with Inits has been a seamless and highly rewarding experience. Their professionalism, technical expertise, and commitment to delivering quality services have greatly contributed to the success of our project. We highly appreciate their collaborative approach and responsiveness, which have helped us meet our goals efficiently. I would strongly recommend Inits to any company looking for a reliable and innovative partner »
Samuel SALOT, COO
« INITS has been a crucial partner in advancing our CMC activities, providing exceptional expertise across process and analytical development, GMP manufacturing, quality support, and IMP management. Their comprehensive support in managing complex projects, from early stage development to regulatory dossier preparation, has been instrumental in keeping us on track and meeting key milestones. What sets INITS apart is their proactive approach. They not only help us overcome current challenges but also anticipate potential hurdles, offering tailored solutions that streamline both the technical and regulatory aspects of our projects. Their team’s ability to seamlessly integrate with our operations have been key to our success. I highly recommend INITS to any company seeking reliable, expert consulting in CMC activities. They are true partners in every sense, and their technical knowledge, industry expertise, and commitment to quality have been critical in advancing our programs. »
Thierry BORDET, CSO
« Inits has been supporting me in all my Quality activities for 3 years now, always with professionalism. The team at Inits is very experienced and reactive. It is a real pleasure to work with them ! »
Delphine JOYEUX, Regulatory Affairs and Quality Director
« We have collaborated with INITS on several occasions, including the preparation of regulatory dossiers, submissions, and interactions with EU health authorities for the approval of our clinical programs. Additionally, their CMC expertise has been invaluable for the selection of CDMOs, the development of complex manufacturing processes for biologics, and associated comparability exercises. Working with INITS has always been rigorous and relevant, combining flexibility, responsiveness, and a collaborative spirit in a consistently pleasant atmosphere. »
Benoit REY, Head of Program Management & CMC
« RevImmune has been working with INITS since several years, on different aspects of product development (CMC/regulatory, Quality management and IMP management). The team is very reactive and supportive. It’s always a pleasure to interact with a such a dynamic team. »
Anne GREGOIRE, Director Process Development
« Through Smart Immune's CMC and clinical projects and the development of our SMART101 product, I have greatly appreciated INITS' support. It has provided us with a human quality in our professional relations, but above all with cutting-edge technical expertise and sound advice, enriched by an entrepreneurial vision. The responsiveness of Christelle, Isabelle, Laura, and Margot in leading the pharmaceutical development of our MTIs was essential to our success and our clinical ambitions. Many thanks for your ability to adapt and your invaluable ongoing support for Smart Immune. »
Pierre HEIMENDINGER, CTO
« During the CMC and development projects for our SMART101 cell therapy product, I was fortunate to benefit from the expertise provided by INITS. INITS has been involved for several years in Smart Immune's entrepreneurial adventure, both in the regulatory CMC aspects and in transferring the manufacturing process to CDMO. The invaluable advice and human qualities that characterize the INITS teams have enabled us to complete our development program successfully. My warmest thanks to Christelle, Laura, Isabelle, and Margot for their involvement and support for Smart Immune's projects and teams. »
Sébastien OSTER, Head of Pharmaceutical Development

What Our Clients Say

« INITS supported us in our first request for a scientific opinion from the EMA to validate our CMC strategy. We were extremely satisfied with the collaborative approach to regulatory dossier preparation, submission and interaction with the regulatory authorities. Many thanks to INITS for their professionalism and responsiveness. We're already planning what's next with the brilliant Inits team! »
Jeanne VOLATRON, CEO of EVerZom
« I would like to express my sincere recommendation about Inits as a professional consulting and supporting partner. Inits’ highly skilled team supported our vision, focusing on our requirements, and entirely completed each task in the expected timing. Inits team was contracted for supporting the CMC development of several programs. Our requests ranged from specific advice on the development of manufacturing process and analytical characterization and quality controls, to support writing documentation dedicated to regulatory scientific advice. Each time, the well experimented Inits team brought its experience, the last trends and regulatory bodies expectations. They provided appropriate recommendations to support the development of compliant product and consistent advice to address technical issues. The added values of Inits are its rapid responsiveness, their precise and well-founded answers, the fairness and honesty of their answers, a very good listening and friendly exchanges. Inits also provided a very complete GMP compliance training to most of the Coave Therapeutics team. In addition to the highly professional content, the pleasant atmosphere of the training eased the team learning. »
Nicole BRUMENT, VP CMC & Supply Chain
« Working with Inits has been a seamless and highly rewarding experience. Their professionalism, technical expertise, and commitment to delivering quality services have greatly contributed to the success of our project. We highly appreciate their collaborative approach and responsiveness, which have helped us meet our goals efficiently. I would strongly recommend Inits to any company looking for a reliable and innovative partner »
Samuel SALOT, COO
« INITS has been a crucial partner in advancing our CMC activities, providing exceptional expertise across process and analytical development, GMP manufacturing, quality support, and IMP management. Their comprehensive support in managing complex projects, from early stage development to regulatory dossier preparation, has been instrumental in keeping us on track and meeting key milestones. What sets INITS apart is their proactive approach. They not only help us overcome current challenges but also anticipate potential hurdles, offering tailored solutions that streamline both the technical and regulatory aspects of our projects. Their team’s ability to seamlessly integrate with our operations have been key to our success. I highly recommend INITS to any company seeking reliable, expert consulting in CMC activities. They are true partners in every sense, and their technical knowledge, industry expertise, and commitment to quality have been critical in advancing our programs. »
Thierry BORDET, CSO
« Inits has been supporting me in all my Quality activities for 3 years now, always with professionalism. The team at Inits is very experienced and reactive. It is a real pleasure to work with them ! »
Delphine JOYEUX, Regulatory Affairs and Quality Director
« We have collaborated with INITS on several occasions, including the preparation of regulatory dossiers, submissions, and interactions with EU health authorities for the approval of our clinical programs. Additionally, their CMC expertise has been invaluable for the selection of CDMOs, the development of complex manufacturing processes for biologics, and associated comparability exercises. Working with INITS has always been rigorous and relevant, combining flexibility, responsiveness, and a collaborative spirit in a consistently pleasant atmosphere. »
Benoit REY, Head of Program Management & CMC
« RevImmune has been working with INITS since several years, on different aspects of product development (CMC/regulatory, Quality management and IMP management). The team is very reactive and supportive. It’s always a pleasure to interact with a such a dynamic team. »
Anne GREGOIRE, Director Process Development
« Through Smart Immune's CMC and clinical projects and the development of our SMART101 product, I have greatly appreciated INITS' support. It has provided us with a human quality in our professional relations, but above all with cutting-edge technical expertise and sound advice, enriched by an entrepreneurial vision. The responsiveness of Christelle, Isabelle, Laura, and Margot in leading the pharmaceutical development of our MTIs was essential to our success and our clinical ambitions. Many thanks for your ability to adapt and your invaluable ongoing support for Smart Immune. »
Pierre HEIMENDINGER, CTO
« During the CMC and development projects for our SMART101 cell therapy product, I was fortunate to benefit from the expertise provided by INITS. INITS has been involved for several years in Smart Immune's entrepreneurial adventure, both in the regulatory CMC aspects and in transferring the manufacturing process to CDMO. The invaluable advice and human qualities that characterize the INITS teams have enabled us to complete our development program successfully. My warmest thanks to Christelle, Laura, Isabelle, and Margot for their involvement and support for Smart Immune's projects and teams. »
Sébastien OSTER, Head of Pharmaceutical Development

« INITS supported us in our first request for a scientific opinion from the EMA to validate our CMC strategy. We were extremely satisfied with the collaborative approach to regulatory dossier preparation, submission and interaction with the regulatory authorities. Many thanks to INITS for their professionalism and responsiveness. We're already planning what's next with the brilliant Inits team! »
Jeanne VOLATRON, CEO of EVerZom
« I would like to express my sincere recommendation about Inits as a professional consulting and supporting partner. Inits’ highly skilled team supported our vision, focusing on our requirements, and entirely completed each task in the expected timing. Inits team was contracted for supporting the CMC development of several programs. Our requests ranged from specific advice on the development of manufacturing process and analytical characterization and quality controls, to support writing documentation dedicated to regulatory scientific advice. Each time, the well experimented Inits team brought its experience, the last trends and regulatory bodies expectations. They provided appropriate recommendations to support the development of compliant product and consistent advice to address technical issues. The added values of Inits are its rapid responsiveness, their precise and well-founded answers, the fairness and honesty of their answers, a very good listening and friendly exchanges. Inits also provided a very complete GMP compliance training to most of the Coave Therapeutics team. In addition to the highly professional content, the pleasant atmosphere of the training eased the team learning. »
Nicole BRUMENT, VP CMC & Supply Chain
« Working with Inits has been a seamless and highly rewarding experience. Their professionalism, technical expertise, and commitment to delivering quality services have greatly contributed to the success of our project. We highly appreciate their collaborative approach and responsiveness, which have helped us meet our goals efficiently. I would strongly recommend Inits to any company looking for a reliable and innovative partner »
Samuel SALOT, COO
« INITS has been a crucial partner in advancing our CMC activities, providing exceptional expertise across process and analytical development, GMP manufacturing, quality support, and IMP management. Their comprehensive support in managing complex projects, from early stage development to regulatory dossier preparation, has been instrumental in keeping us on track and meeting key milestones. What sets INITS apart is their proactive approach. They not only help us overcome current challenges but also anticipate potential hurdles, offering tailored solutions that streamline both the technical and regulatory aspects of our projects. Their team’s ability to seamlessly integrate with our operations have been key to our success. I highly recommend INITS to any company seeking reliable, expert consulting in CMC activities. They are true partners in every sense, and their technical knowledge, industry expertise, and commitment to quality have been critical in advancing our programs. »
Thierry BORDET, CSO
« Inits has been supporting me in all my Quality activities for 3 years now, always with professionalism. The team at Inits is very experienced and reactive. It is a real pleasure to work with them ! »
Delphine JOYEUX, Regulatory Affairs and Quality Director
« We have collaborated with INITS on several occasions, including the preparation of regulatory dossiers, submissions, and interactions with EU health authorities for the approval of our clinical programs. Additionally, their CMC expertise has been invaluable for the selection of CDMOs, the development of complex manufacturing processes for biologics, and associated comparability exercises. Working with INITS has always been rigorous and relevant, combining flexibility, responsiveness, and a collaborative spirit in a consistently pleasant atmosphere. »
Benoit REY, Head of Program Management & CMC
« RevImmune has been working with INITS since several years, on different aspects of product development (CMC/regulatory, Quality management and IMP management). The team is very reactive and supportive. It’s always a pleasure to interact with a such a dynamic team. »
Anne GREGOIRE, Director Process Development
« Through Smart Immune's CMC and clinical projects and the development of our SMART101 product, I have greatly appreciated INITS' support. It has provided us with a human quality in our professional relations, but above all with cutting-edge technical expertise and sound advice, enriched by an entrepreneurial vision. The responsiveness of Christelle, Isabelle, Laura, and Margot in leading the pharmaceutical development of our MTIs was essential to our success and our clinical ambitions. Many thanks for your ability to adapt and your invaluable ongoing support for Smart Immune. »
Pierre HEIMENDINGER, CTO
« During the CMC and development projects for our SMART101 cell therapy product, I was fortunate to benefit from the expertise provided by INITS. INITS has been involved for several years in Smart Immune's entrepreneurial adventure, both in the regulatory CMC aspects and in transferring the manufacturing process to CDMO. The invaluable advice and human qualities that characterize the INITS teams have enabled us to complete our development program successfully. My warmest thanks to Christelle, Laura, Isabelle, and Margot for their involvement and support for Smart Immune's projects and teams. »
Sébastien OSTER, Head of Pharmaceutical Development

INITS Is a Group of Talents

We are passionate and committed about what we do, we dare to take different and innovative approaches. Our collective mission is to provide expert guidance and unwavering support to biotechnology companies with a blend of experience, passion, and innovation.

We dare to think out of the box and we challenge everything in due time.

Meet our team

For inquiries or to explore how our services can benefit your specific needs, please