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
  • 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