CRO expert services provision

CRO expert services provision
Product Description

Clinical trials: patients’ recruitment,clinical trials site,bioanalytical testing,contract research support,clinical and post-marketing PVLicensing-in & Licensing-out BD and project management.Pre- and post MA regulatory affairs: GAP analysis,EU MAH, EU CTD file, MA preparation and submission,medical and technical writing,scientific advice,CMC,product lifecycle management, DMF, CEP 
Regulatory strategy consulting:
QMS GxP: EU GMP, GACP, QP, RP. QMS setting up complying with cGxP,due diligence GAP,EU QP,RP,WDA-WDL,pre-approval audits
Pharmacovigilance EU QPPV

PHA FARMED d.o.o.

  • SI
  • 2023
    On CPHI since
  • 1
    Certificates
  • 1 - 24
    Employees
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
Primary activities
Contract Research Organisation
Out-licensing specialist
Specifications
  • Details
    CUSTOMER ORIENTATION - PERSONAL RESPONSIBILITY - CREDIBILITY – PARTNERSHIP

  • Selling Points
    Serving to pharmaceutical companies:human medicines, veterinary medicines
    medical devices
     
  • Model
    Project management tailor made to client's needs
  • Supplied from
    Slovenia

PHA FARMED d.o.o.

  • SI
  • 2023
    On CPHI since
  • 1
    Certificates
  • 1 - 24
    Employees
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
Primary activities
Contract Research Organisation
Out-licensing specialist