Cosmetic industries

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 of new assets
    Patent filing (IP)
    Scientific monitoring

    Development of new formulas:
    Development and optimisation of the formula
    Analytical development
    Galenic development
    Stability studies, packaging

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

    Quality Control

    Optimisation and Validation of analytical methods
    Physico-chemical and microbiological controls of PM, IP, PF and packaging items
    Implementation of the control methodology (sampling, frequency, retention of samples, etc.)
    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 cosmetics, 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

    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

    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 ISO 22 716, etc.
    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

    Operational QA

    Management of deviations, anomalies and non compliance
    Technical research
    CAPA Management
    Change Control Management
    Customer Complaints management
    Management of production documentation, validation procedures, instructions, release of batches
    Creation of Product Quality Reviews
    Environmental follow-up (ZAC…)
    Implementation of management tools (access, Excel, specific software)
    Release of batches

  • 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 (liquid, pasty and semi-pasty forms)
    Cleaning validation (manual, semi-automatic, CIP) or sterilisation
    Analytical, physicochemical & microbiological method validation
    Validation of storage and transport

    VSI – VSA

    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

    Regulatory regulation
    Answers to questions from regulatory authorities
    Control of labelling information and various communication media
    Validation of allegations
    Constitution and publication of the Product Information Files and European Legal Files
    Notification of products on the internet portal of the European Commission
    Technical and regulatory monitoring of products
    Management of Export dossiers
    Validation of formulas in accordance with standards and regulations
    Validation of packaging elements

    Registration and Submission

    Definition and implementation of a technical-regulatory strategy


    Collection, entry and management of PV data
    Interface with users, 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 test 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

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

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