Our Services

MBS Consulting offers short to long-term services

Our Services

MBS Consulting offers short to long-term services.

Interim / Replacement

Operational Support

Strategic Advice

Team Supervision

Our Expertise

Our experts can support you.

CMC Regulatory Affairs

Regulatory strategy :

  • Advise during development phases ;
  • Help to prepare Agency meetings ;
  • Support clinical trials and marketing applications.

Geographical expansion : 

  • Expertise with China, Japan, Middle East, Russia, ASEAN and LATAM countries and international markets (EU, US and Canada).

CMC writing : build and write the CMC sections in a high-quality by presenting data in compliance with Health Authorities’ requirements :

  • INDs/IMPDs ;
  • Briefing package ;
  • Biowaivers ;
  • Modules 3 and 2.3 of NDAs/BLAs/MAAs ;
  • Regulatory responses ;
  • Risk analysis and Technical files.

Life-cycle management :

  • Manage and follow the annual updates and the renewals ;
  • Plan, build and write variations & supplements, including site transfers.

Strong CMC & GMP experience with drugs (small and large molecules), vaccines, biologicals, medical devices, food supplements and cosmetics.

Quality Assurance

 Quality Management System (GMP and GDP)

    • Support to develop and improve Quality Management System (QMS)
    • Act as Responsible Person
    • QA oversight of Contract Manufacturing Organization (CMO) and Contract Laboratory Organization (CLO)
    • Review and approve documents of GMP systems and related changes and deviations
    • Take leadership for the resolution of issues
    • Issue and review Product Quality Review (PQR)
    • Issue and discuss Quality Agreements with external parties 

Audit and inspection

    • Plan, perform and follow external and internal audits
    • Support regulatory inspections (Swissmedic, FDA, etc…)


    • Perform QA training to the teams

Analytical Science & Technology

Analytical Subject Matter expert:

    • Cover analytical aspects during project development and life-cycle for drugs including biologics
    • Support analytical method development, qualification, validation and transfer
    •  Investigate analytical issues
    • Experience with formulation, characterization, comparability, compatibility studies as well as release and stability including specifications
    • Management of critical reagents (e.g. reference standards)
    • Compile and review analytical documentation (method, protocol, reports…)
    • Ensure compliance and traceability of analytical changes through deviation and change management systems/softwares, including risk assessment
    • AQR/PQR support
    • CMC module 3 updates for regulatory submissions, variations, market expansion, annual reporting to authorities
    • Provide feedback to analytical requests from regulatory agencies

Analytical Project lead/management:

    • Follow up of project progress (meetings, minutes, action tracker) such as analytical technology transfer
    • Coordinate analytical activities with cross functional teams, including with external suppliers (e.g. CMOs, CLOs)

Chemoinformatics & Computational Chemistry

Our computational services are designed to empower researchers and organizations with the tools they need to extract valuable insights from chemical data.

    • Chemical Data Analysis : Advanced data mining and analysis tools to extract meaningful information from chemical databases ;
    • Virtual Screening : High-throughput virtual screening of chemical compounds, to identify promising drug candidates and reduce the time and cost ;
    • QSAR Modeling : Quantitative Structure-Activity Relationship (QSAR) modeling to predict the biological or chemical activity of compounds ;
    • Chemical Property Prediction : Accurately predict various chemical properties such as solubility, toxicity, and bioavailability, guiding decision-making in drug development ;
    • Chemical Database Management : Organize, curate, and manage chemical databases efficiently, ensuring data integrity and accessibility ;
    • Machine Learning in Chemoinformatics : Predictive models to classify compounds and optimize chemical processes.

your journey