Pharmacovigilance & medical safety

  • ICSR , PSUR , PADER , PBRER , RMP , aRMM , CE mark evaluation , PMCE , SMP , ignal Detection , ISS , Literature Management , PSMF , QPPV , PVA , Audits and Inspection

Clinical Trial (Phase I-IV) Management

  • Study Design , Feasibility , Regulatory Applications , Training , Site selection , Project Management , Medical Monitoring , Safety Monitoring , Site Development and Support PMS , IIS , PAP , CUS , Active Surveillance , Immunogenicity , Epidemiology Studies , Prescription Use Studies

Medical Writing

  • Protocol , Synopses , Clinical Study Report , Regulatory Scientific advise documents , Labels/Patient Information Leaflets RWE Data Collection , RWE Data Analysis , Publication

Drug Development

  • NPD evaluation , Lifecycle Management Strategies , Program Development , Product USP creation

Business Development Support

  • RFP , Proposals and Contracts , Client Communication , Lead Generation ,Branding Strategies

Technology

  • PV Intake and Literature Automation Support Tools , Case Processing Software , eCRF/ARGUS/Lifesphere(ARISG) , IRMS , Medidata

Quality and Compliance

  • GCP , GVP , GDP , ALCOA+

Regulatory Expertise

  • IND , NDA , BLA , 505(b)(2) , 351(k) , EU-MDR , USFDA , EMA , ANVISA

Product Expertise

  • Drug , Vaccines , Medical Devices , Combination Products , ATMP , Gene Therapy , Biologics , Biosimilars , Cosmetics

Therapeutic Areas Experience

  • Oncology , Neurology , Psychiatry , Cardiology , Pain , Dermatology , Rheumatology , Gynecology