Our pharmaceutical division supports pharmaceutical laboratories and biotechnology companies in the development of new products, production and batch release as well as compliance with regulatory, quality and clinical requirements.

  • R&D Laboratory

    Research & Development

    Research projects
    Patent filing (IP, filing and PTC application)
    Scientific monitoring
    Genetic engineering

    Pharmaceutical development:
    Analytical development
    Galenic development/Optimisation of the formula
    Stability studies, packaging
    Establishment of experimental design (NemrodTM, DesignExpertTM)/Trouble shooting
    QBD and risk analysis (AMDEC)
    Development of the upstream process
    Development of the downstream process

    Industrial development:
    Implementation and/or optimisation of the manufacturing process
    Scaling up
    Technological transfer

    Quality Control

    Optimisation and Validation of analytical methods (including bioburden and endotoxins, …)
    Physico-chemical and microbiological controls of PM, IP, PF and packaging items
    Implementation of the control methodology
    – Sampling strategy (sampling, frequency)
    – Conservation of samples
    Control and monitoring of product stability (on-going stability)
    Management of deviations linked to the laboratory activity
    Analysis of anomalies, OOS and OOT and follow-up of investigations
    Drawing up protocols and analytical reports
    Carrying out inter-laboratory Gap analysis/ methods
    Review of the analytical part of the batch dossier
    Data integrity
    Deployment of the requirements of the specifications: GMP, GLP, ICH, etc.

  • Production

    New works and maintenance

    Management of technical affairs
    Coordination between the different departments (quality, purchasing, production, finance, etc.)
    Project monitoring from the definition of the URS until the commissioning of equipment/ utilities / buildings)
    Implementation of the maintenance strategy (curative, preventive and ameliorative)

    New works & revamping
    Design of manufacturing, packaging, cleaning or serialisation lines
    Design of utilities and/or buildings
    Sizing of bioreactors

    Supply Chain

    Analysis and monitoring of transport conditions (logistical complaints, temperature excursions, etc.)
    Coordination of recalls/ batch withdrawals
    Change control and CAPA monitoring at the level of the distribution chain
    Establishment/modification of distribution channels
    Support for depositaries
    Qualification of the suppliers
    Monitor the implementation and compliance with BPDG

    QHSE Technical Supervision

    Extension projects, maintenance, shutdowns
    Creation of safety receptions, prevention plan, fire permits and management of the DI system
    Verification of the qualification of the participants, the conformity of the equipment
    Occupational Risk Assessment
    Assistance in setting up and monitoring means of protection (EPI/EPC)
    Control of the good practice of the applicable standards and instructions (auditing)
    Specific Missions:
    – ISO14001:2015, OHAS18001:2007, ISO45001:2018, MASE
    – ICPE dossiers, chemical risk assessment, ATEX study

  • Quality Assurance

    QA system

    Implementation and Optimisation of the SMQ
    Deployment of normative requirements and GxP, ISO 9001, ICH benchmarks
    Identification and mapping of processes
    Preparations for inspections (ANSM, FDA) and for internal audits
    Document management (Writing of SOP, WI, quality manual …) and implementation of GED
    Risk management approach
    Audit, gap analysis
    AQ Suppliers, supplier audits, subcontractors
    Normative and regulatory regulation
    Identification and drafting of procedures, work instructions and operating methods
    Implementation of management tools (access, Excel, specific software)

    Operational QA

    Management of deviations, anomalies and non compliance
    Technical research
    CAPA Management
    Change Control Management
    Customer Complaints management
    Creation of Product Quality Reviews
    Environmental monitoring (periodic review of ZACs, etc.)
    Intégrité des données
    Release of batches
    Maintaining sterility:
    – risk management of microbiological contamination (microbial and viral)
    Assessing risks and impact
    Ensuring the microbiological safety of cell banks
    Periodical review of trends

  • Qualification - Validation


    Qualification and validation: initial, retrospective and periodical
    Qualification of Premises and utilities
    Equipment qualification (production, packaging, control, laboratory)
    Management and validation of the V-cycle:
    – Definition of user needs (URS)
    – Drafting specifications
    – Traceability matrix, risk analyses, Validation Master Plan
    – Carrying out tests, and writing reports for the phases of QC, SAT and FAT, QI/QO/QP
    – Validation Report and put into production


    Validation of manufacturing processes
    – Dry form (mixing, granulation, compression, film coating)
    – Liquid form (dissolution, suspension, clarifying filtration, distribution)
    – Sterile form (dissolution, sterilisation, distribution, lyophilisation, sterility test)
    – Biotechnology (Upstream/downstream Process)
    Cleaning validation (manual, semi-automatic, CIP) or sterilisation
    Analytical, physicochemical & microbiological method validation
    Validation of transport

    VSI – VSA

    Serialisation – Aggregation
    Data Integrity
    Automated and computerised systems
    Global and local systems
    Qualification of infrastructures
    Systems involved:
    – LIMS: Laboratory systems
    – MES: Production systems
    – ERP (SAP, SAGE X3,…)
    – Software
    – Excel/VBA macro files

  • Regulatory Affairs

    Consultation and maintenance of dossiers

    Pharmaceutical content
    – Module 3: writing and updating of pharmaceutical and biological data relating to the active ingredients (3.2.S) and the finished product (3.2.P)
    – Variations dossier (IA, IB, II)
    – DMF/ASMF
    Preclinical and clinical content
    – Module 4 : non-clinical data
    – Module 5 : efficacy and safety of clinical data
    Appendices: RCP, instructions, labelling, packaging
    Update of the dossier according to the life cycle of the product (raw materials, manufacturing processes)
    Regulatory developments
    Answers to questions from regulatory authorities
    Drafting of a business opening dossier
    Control of labelling information, advertising
    Publication of dossiers
    Biological Licence Application (BLA) request
    Regulation of biosimilars (comparability exercise, etc.)

    Registration and Submission

    Registration/filing strategy and procedure: National (France), Centralised (EMA), Decentralised, Mutual recognition
    Reformatting of dossiers (e-CTD)


    Collection, entry and management of PV data
    Drafting of PSUR, DSUR, PGR
    Interface with healthcare professionals, authorities and internal partners

  • Clinical Affairs

    Implementation of clinical studies

    Drafting of key documents
    Submission of documents to the relevant authorities
    Managing amendments
    Development of clinical trial protocols
    Clinical research
    Data Management
    Managing the clinical project
    Coordination of clinical trials

    Selection and monitoring of CRO

    Benchmarking of a pre-defined panel
    Logistics of research centres

    Post Market Surveillance

    Drafting of PSUR, PBRER and clinical overview
    Signal reports
    Presentation of results and summaries to the evaluation committee

dossiers filed to the relevant authorities
clients with whom we work regularly
Consultants specialised in life sciences careers

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