“Exploitant” sites
Towards predictive and individualised medicine
Our positioning enables us to work on the overall life cycle of a health product.
Areas of expertise
Services
- Submitting of market release authorisation documents, renewal, variations
- Drafting, submitting and tracking of specific regulatory applications (temporary utilisation authorisations – ATU, clinical tests, market access, etc.)
- Product registration (CE marking)
- Maintenance and regulatory watch
- Advertising supervision
References and technical expertise
- Constitution of market release authorisation documents for the world-wide registration of a new heart treatment drug, validation of inserts and labelling, SPC, packaging
- Drafting of transparency documents, price-reimbursement, setting up of medical-economic studies
- Validation of promotional items for drugs, medical systems and cosmetics
- Repositioning of a cosmetic product as a medical system, regulatory watch in several countries (USA, EU, Japan, Korea, China), recommendation and registration
Services
- Coordination and management of clinical studies
- Assistance for clinical research (CRAs, etc.)
- Clinical Quality Assurance
- Bio-statistics / Biometrics (data management, statistical analysis, etc.)
- Publishing
References and technical expertise
- Management of international and local pharmaceutical and epidemiological clinical studies (Hepatitis B and C, Oncology), management and coordination of sub-contractors, prediction, planning, budget supervision and control, collaboration with medical management and regional practitioners
- Operational management of a temporary utilisation authorisation (ATU) (melanoma metastasis symptoms) and management of local observational studies in infectiology
- Clinical quality assurance of studies in neuro-psychiatry, quality management, training relating to regulations and to the conducting of clinical tests, drafting and proof reading of procedures
- Drafting statistical analysis plans, reporting, summary and interpretation of clinical study results in oncology
Services
- Quality assurance (CAPA management, etc.)
- Documentary quality control
- Updating of quality system / Drafting of procedures / Personnel training
- Compliance
- Audit
- IS validation
References and technical expertise
- Application of standard ISO 13485 in a medical systems startup, drafting of procedures, preparation of quality system forms, creation of the documentary system, drafting of procedures, awareness of personnel
- Updating and supervision of a documentary system in a pharmaceutical laboratory, management of local and group procedures, conducting and supervision of internal audits
- Drafting and application of procedures related to interventional and non-interventional clinical studies, in accordance with regulations, regulatory watch
- Achieving compliance of the information systems (IS) of the clinical pharmacokinetics (CPK), in accordance with international requirements and IS validation (drafting of validation protocols and reports, supervision of tests)
- Drafting of statistical analysis plans, reporting, summary and interpretation of clinical studies results in oncology
Services
- Management of cases (collection, documentation, recording, assessment, declaration undesirable effects)
- Scientific watch
- Management of SDEAs
- Drafting of PSURs / DSURs
- Management of requests for medical information (health professionals and patients)
References and technical expertise
- Collection and analysis of cases of undesirable effects in a pharmaceutical laboratory: documentation of PV cases and treatment in compliance with internal procedures, tracking of PV cases with notifiers for collection of complete data
- Setting up and drafting of local procedures related to the pharmaco-vigilance activities of a pharmaceutical laboratory, preparation and involvement in a compliance audit conducted by the laboratory Corporate Pharmacovigilance
- Drafting and supervision of Safety Data Exchange Agreements (SDEAs) with partners and drafting monthly PV reports for the international PV teams of a pharmaceutical laboratory
- Preparation of periodic safety update reports (PSUR), PV bibliography watch, collection and analysis of data relating to PV cases, identification of cases of interest and drafting of reports
Quality policy
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Quality Management System
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Health, Safety, Environment