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TECHNICAL & REGULATORY SERVICES

  TECHNICAL &
  REGULATORY SERVICES

GMP Healthcare has an extensive hands-on experience in delivering technical projects for our clients. Our experienced team spent their working lives within the pharmaceutical, biological, biotech and medical device industry.

Our technical & regulatory services, but not limited to, are as follows:

FACILITY DESIGN & QUALIFICATION

CONTAMINATION CONTROL STRATEGY

TECHNOLOGY TRANSFER

PACKAGING TRANSFER

PROCESS OPTIMISATION

PRODUCT/PROCESS TECHNICAL STUDIES

PACKTECH ASSESSMENT

REMEDIATION SUPPORT

TEMPERATURE MAPPING

TRANSPORT ROUTE QUALIFICATIONS

METHOD VALIDATION

STABILITY MANAGEMENT

EXCIPIENT RISK ASSESSMENT

PHARMACOVIGILANCE

REGULATORY STRATEGY PREPARATION

REGULATORY DOSSIER PREPARATION

MIA/MA/WDA LICENSING SUPPORT

REGULATORY GAP ASSESSMENTS