“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

They trust us

  • agap2_logo-client_sanofi_680x628.jpg
  • agap2_logo-client_gsk_680x628.jpg
  • agap2_logo-client_novartis_680x628.jpg