Team

Our Team

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Marietta Santos

CEO, MSc, CMC Regulatory Affairs Consultant

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Emilie Meynet-Meunier

MSc, CMC Regulatory Affairs Consultant

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Marie Dréan-Corbier

MSc, Analytical Development and QC Consultant

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Marie Dréan-Corbier

MSc, Analytical Development and QC Consultant

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Marion Dreyfus

PharmD, QA Consultant

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Our objectives

Clients Support

We aim to provide our clients with the right service and meet their expectations.

Long-term
Relationships

We aim to be a trust partner by providing high-quality delivery in due time.

High Impact

We aim to contribute to the development and approval of innovative pharmaceutical and biotechnology products for the benefit of patients and society.

CMC Intelligence

We aim to stay at the forefront of the compliance, regulatory changes and advancements in the industry by investing in continuous learning and development.

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We aim to be a trusted reference in drug innovation and CMC at all stages of the product lifecycle, from pre-clinical to post-approval.

Marietta Santos

CEO

FACTS AND FIGURES

Experts
1
Countries covered
20 +
Offices, in Geneva and in Montreal
0
of regulatory approval
50 %+

Supporting
your journey

FORWARD.

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Marietta Santos

MSc, CMC Regulatory Affairs Consultant

Consultant with over 15 years of experience in the pharmaceutical industry, Marietta has a proven track record of successfully navigating complex regulatory requirements for a wide range of products. She has a deep understanding of global CMC regulatory requirements, including those of the FDA, EMA, and other international regulatory bodies. 

Marietta began her career in Quality Assurance, then CMC development and turned CMC regulatory affairs where she became a senior manager in CMC regulatory affairs department in a major pharmaceutical company. She then transitioned to consulting, where she has worked with a diverse range of clients in the pharmaceutical and biotech industries. 

Throughout her career, Marietta has been instrumental in the development, submission, and approval of numerous drug products. She has a strong background in the development and implementation of CMC strategies, as well as a thorough understanding of GMP, GLP, and GCP regulations. In addition to her technical expertise, Marietta is known for her excellent communication and project management skills. She is able to effectively lead cross-functional teams and work closely with clients to ensure their regulatory
needs are met.

Sigantures mbs Marion
image d'Emilie sur fond blanc

Emilie Meynet-Meunier

MSc, CMC Regulatory Affairs Consultant

Emilie has around 15 years’ experience in Regulatory CMC within companies of varied sizes and therapeutic areas, covering the entire life cycle of products (chemical drugs, vaccines, medical devices, drug-device combinations, cosmetics, food supplements) from early development through clinical studies, marketing authorization applications and post-authorization activities.

She recently contributed to the EU marketing authorization in centralized procedure for an innovative product and over her experience to many geographical expansions worldwide (EU, US, Canada, Japan, LATAM, Middle East and ASEAN countries).

Emilie has an extensive expertise in both, the regulatory and strategic advice in pharmaceutical development & LCM, and the writing or reviewing of CMC documentation (Modules 3 and 2.3, INDs, IMPDs, NDAs, MAAs, variations and regulatory responses in global markets). She has also a proven experience as Quality Assurance Manager and with the new European regulation of medical devices (MDR).

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images Marie Dréan-Corbier sans fond

Marie Dréan-Corbier

MSc, Analytical Development and QC Consultant

Marie has more than 10 years of experience in the analytical field over a broad range of functions that support drug development and commercialization, with a focus on biological products. She acted as a scientist/subject matter expert, headed analytical and bioanalytical teams and led projects such as analytical technology transfers.

Marie has a strong background in interacting with external partners such as CMOs, CLOs and is used to effective collaboration with QA, regulatory and technical expert functions.

She is working closely with applicable guidelines and pharmacopeias, allowing to meet product development requirements.

Marie has been involved in CMC activities from early stages of product development through commercialization to different countries and post-life cycle management of analytical activities, including method development, validation, transfer, stability studies and technical support for registration. She can also support drug substance/product formulation activities, characterization studies, comparability and compatibility work. Technical writing/reviewing of eCTD documentation related to analytical sections and answering to regulatory agency requests is also part of her experience.

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Marion Dreyfus

PharmD, QA Consultant

Marion has 15 years’ experience in Pharmaceutical Companies as a PharmD specialized in Quality Assurance and she is a GMP and GDP expert.

Marion has always worked within Quality Assurance team, in international companies of varied sizes and for pharmaceutical and biotech industries. She worked, as a QA operational, on manufacturing sites (sterile and non-sterile) and as well by managing external Contract Manufacturing Organization (CMO) and Contract Laboratory Organization (CLO).

Marion has an expertise with the QA oversight of external partners like the management of external audits, quality agreement, product quality review, deviations, CAPA, technical release and risk assessment and can act as a Responsible Person (or deputy) in Switzerland.

She has an extensive expertise as well with the management of internal QA systems like the management of internal audit, inspection preparation and training. She used to work closely with CMC team as a QA partner for different projects like submission.

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