2 October 2016

Services

Pharmalogics usługi

Medical and Chemistry/ Manufacturing
Controls expertise for Regulatory Affairs

  • CTD dossiers preparation, updates and addenda for generic, hybrid, well-established use and innovator medicinal products
  • CTD dossier due-diligences prior to submissions, licensing or acquisitions
  • OTC dispensing status variations and disputes with Health Authorities
  • Medical and CMC advisory services and MA-obtaining feasibility assessments
  • Scientific discussions with Health Authorities
  • Environmental Risk Assessments

Pharmalogics usługi

Medical Affairs support

  • Non-clinical and clinical research scientific support (e.g. study assumptions and protocol synopsis preparation)
  • Research protocols reviews and assessment
  • Clinical sites audit on behalf of sponsor, including pre-study commencing CRO suitability audits
  • Medical Advisor services outsourcing: sales reps trainings, Regulatory Affairs
    and Marketing departments medical support, Medical Information services

Pharmalogics usługi

Medical services for the development of Medical Devices

  • Clinical Evaluation Reports
  • Biological Evaluation Reports
  • Audits of biocompatibility dossier vs ISO 10993 standards series