Pharmaceutical

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Pharmaceutical expert center


According to its strong experience in the health field, CaduCeum provide you with its expertise concerning Clinical and Scientific Affairs (CSA) in the following fields:

Medical Devices / In Vitro Diagnostic Medical Devices / Pharmaceuticals / Cosmetics

FIELD OF COMPETENCY

  • Manage all Clinical and Scientific literature project or review
  • CaduCeum’s dedicated service
  • Multi-disciplinary team with the requested skills (PhD, PharmD, Engineers, …)

TAILORED SERVICE

  • All products ⁄ devices in health field
  • Dedicated starting meeting for each project
  • Regular follow-up meetings with the customer
  • Writing of the final report, reviewed and validated with the customer
  • Regulation’s requirements taken into account

CLINICAL & SCIENTIFIC LITERATURE

  • Bibliographic research protocol establishment
  • Selection of relevant articles from specialized databases
  • Critical analysis and synthesis of selected articles

SERVICES

  • Clinical or Performance evaluation report:
    • Complete writing
    • Gap analysis
  • Proof of Concept (PoC)
  • Protocol for Post Market Clinical Follow-up (PMCF)
  • Bibliographic validation of the indication of a product
  • Non Clinical and Clinical Summaries & Overviews (CTD 2.4, 2.5, 2.6, 2.7)
  • Periodic Safety Update Report (PSUR)
  • Articles bibliographic surveillance (according to customer’s criteria)
  • Writing of articles, abstracts, posters or any kind of scientific publication
  • Clinical project:
    • Clinical study protocol writing and registration dossier
    • Selection of investigative sites

RISK ANALYSIS AND FMEA DEPLOYMENT

  • Failure mode and effect analysis

INDUSTRIAL MAINTENANCE

  • Shutdown : coordination, planning, preparation and follow-up of annual shutdown

TECHNICAL MANAGER

  • From specifications to commissioning of equipment ⁄ utilities ⁄ buildings

PROJECT MANAGEMENT

  • Cross-cutting quality, regulatory, technical, financial approach

COMMISSIONING EQUIPMENT, UTILITIES, ROOMS / HVAC

  • Specifications, protocols, design review, APS, APD, FAT, SAT

BUSINESS ANALYST

PHARMACEUTICAL QUALITY SYSTEM

  • SQP creation or compliance
  • Deployment of quality risk management
  • Deviation management, CAPA and Change control
  • Product quality review
  • Batch file review

DOCUMENT MANAGEMENT

  • Creation or update of the documentary system, procedures, instructions and operating procedures

QUALITY CONTROL

  • Development and validation of test methods

EXTERNALIZED ACTIVITIES

  • Creation or update of the supplier evaluation system
  • Writing the quality agreement
  • Definition and management of the transfer of manufacturing activities

COMPLAINT

  • Management of complaints

COMMISSIONING / QUALIFICATION / VALIDATION

  • VDP ⁄ VMP site
  • Steering ⁄ structured project management
  • Project risk analysis
  • VDP ⁄ VMP project with strategy development and business planning
  • Process risk analysis, equipment
  • Writing user specifications (CCU ⁄ URS)
  • Participation in FAT ⁄ SAT
  • QC ⁄ QI ⁄ QO ⁄ QP ⁄ VP ⁄ VN deployment
  • Transport verification
  • Periodic Review
  • Field of application
  • Production, laboratory equipment, utilities (EPPI, EPU, VP, ACP, N2, HVAC), Premises, Environmental Systems, Processes

AUDIT

  • Audit management (internal, suppliers, external)
  • Preparation for audits ⁄ inspections

BUSINESS STRATEGY CONSULTING

  • Diagnosis of the situation
  • Remediation plan
  • Coaching

REFERENTIALS

  • ICH Q2 ⁄ ICH Q8 ⁄ ICH Q9 ⁄ ICH Q10
  • ASTM E2500
  • ISO 9001
  • ISO 14644 ⁄ ISO 14698
  • European Pharmacopée and USP
  • Piloting ⁄ Structured project management

STRATEGY OF MARKETING AUTHORIZATION REGISTRATION

  • Recommendation and implementation of a technical-regulatory and market access
    strategy
  • Submission and management of clinical trial authorisation applications (CTA, IMPD, IND)
  • Submission, management, and follow-up of Pediatric Investigation Plans (PIP)
  • Coordination and planning of registration plans (pharmaceutical, pharmacological, toxicological, clinical records …)
  • Contact with the authorities and management of comments and remarks questions

REGISTRATION AND MARKETING

  • Module 3 writing
  • Expert reports writing: quality (module 2.3.QOS), preclinical (module 2.4) and clinical (module 2.5)
  • Management and submission of registration procedures at European (National, MRP, DCP, CP) and International levels
  • Reimbursement dossiers

PRODUCTS MONITORING AND EXPLOITATION

  • Renewals management, planning and submission
  • Variations management, planning and submission (definition of type of variation, variation file writing, submission and follow-up with the authorities)
  • Marketing authorisation transfer and operator site
  • Pharmacovigilance

PUBLISHING AND UPDATING REGULATORY DATABASES

  • File assembly
  • File publication (Paper, NeeS, eCTD format)
  • Submission through EMA/FDA gateways
  • Update of tracking databases approvals

CUSTOMISED REGULATORY MONITORING

AUDITS AND DUE DILIGENCE

  • Scientific
  • Technico-regulatory
  • Database
  • Organisational

REFERENTIALS

  • BPF / GMP / cGMP
  • BPL / BPD
  • FDA