Services
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…)
Training
- 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.
- Chemical Data Analysis : Advanced data mining and analysis tools to extract meaningful information from chemical databases ;
CMC Regulatory Affairs
we support your regulatory strategy during product development (agency meeting preparation, clinical or marketing authorisations, due diligence) or in lifecycle management (variations, geographical expansions), including the writing of your CMC sections in Health Authorities' requirements.
Quality Assurance
We support you in the management of your Quality systems with GxPs expertise (SOPs, training, audit, inspections , PQRs, QTA, etc). We may act as Responsible Person in the market release of medicinal products and supplier qualification.
Analytical Science and Technology
We provide (bio)analytical support during formulation, development, quality control, including supervision of laboratory team members.
Chemoinformatics and Computational Chemistry
We help you to design new drugs and materials by predicting the structures and properties of molecules, group of molecules, and solids.
