Pharmaceuticals

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Our pharmaceuticals services


Marketing authorization

  • Submission of marketing authorization
    • Preparation of the records
    • Submission to the authorities
    • Consideration of comments and remarks
  • Management of the modules 1 to 5

Statutory conservation

  • Updating the records in accordance with the evolution of regulations, cycle of life of the product (Raw materials, process…)
  • Regulatory monitoring

NORMATIVE ENVIRONMENT

  • BPF
  • GMP
  • FDA

Development of products/ process

  • Formulation
  • Galenic development
  • Analytical transfer

Project Management

  • Budget, planning
  • URS (user requirement specification ) redaction
  • Risk analysis process
  • Supplier management
  • Design qualification/ choice of suppliers
  • Commissioning
  • Revamping
  • Scale-up
  • Continuous improvement

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

  • CaduCeum’s dedicated service
  • Multi-disciplinary team (PhD, PharmD, Engineers, …)
  • Frequent follow-up discussions with the client

TAILORED SERVICE

  • All products / devices in health field
  • Taking into account applicable regulatory requirements

CLINICAL AND SCIENTIFIC LITERATURE

  • Writing reports based on clinical and scientific literature
  • Bibliographic research protocol establishment
  • Selection of relevant articles from specialized databases
  • Critical analysis and synthesis of selected articles

REPORTS

  • Approval field for Competent Authority
  • Proof of concept
  • Bibliographic validation of the product medical indication

all kind of reports based on clinical and scientific literature

OTHER SERVICES REALIZED BY PHARMACEUTICAL EXPERTISE

  • Pharmacovigilance studies
  • Product risk management
  • In vivo/ in vitro tests

 Quality system management

  • Gap analysis
  • Alignment and standardization of procedures
  • Document management ( instructions, procedures, operating procedures …)
  • Staff training Management
  • Preparation of inspections/audits (notified bodies, suppliers, FDA…)

Operational quality assurance

  • Corrective actions and Preventive Actions ( CAPA), abnormalities and deviations management
  • Change control management
  • Customer complaint management
  • Environmental follow-up
  • Supplier quality

Qualification/ Validation

  • FAT/SAT/QI/QO/QP ( controlled atmosphere from class A to D)
  • Cleaning Validation ( manual, semi-automatic and CIP ( cleaning-in-place) )
  • CSV/ ASV ( ERP, Excel sheets, software, automates )

Quality Control

  • Laboratory analysis (HPLC, NMR, IR…)
  • Validation of analytical methods

NORMATIVE ENVIRONMENT

  • ISO 17025
  • USP : US PHARMACOPEIA
  • EP : EUROPEAN PHARMACOPEIA
  • ICH Q7
  • GMP
  • 21 CFR PART 11