+91 94900 30441expert@gxphelpline.com

Industries We Support

Specialized compliance expertise across the life sciences spectrum

Pharmaceuticals

Comprehensive GMP compliance for drug manufacturing operations

Regulatory Challenges

  • Complex manufacturing processes requiring validation
  • Multiple regulatory jurisdictions (FDA, EMA, etc.)
  • Legacy systems needing modernization
  • Continuous process verification requirements

How We Help

  • End-to-end process validation
  • Manufacturing equipment qualification
  • Cleaning validation programs
  • Technology transfer support
  • Annual product reviews

Biotechnology

Specialized compliance for biologics and biosimilars development

Regulatory Challenges

  • Complex biological processes
  • Cell and gene therapy validation
  • Comparability studies
  • Adventitious agent testing

How We Help

  • Bioprocess validation
  • Cell line characterization
  • Biosafety compliance
  • Analytical method validation
  • Stability study protocols

Medical Devices

Device validation and Quality Management System implementation

Regulatory Challenges

  • Design control requirements
  • Risk management per ISO 14971
  • Software validation for devices
  • Post-market surveillance

How We Help

  • Design verification and validation
  • ISO 13485 QMS implementation
  • Software lifecycle validation
  • Clinical evaluation reports
  • Technical file preparation

Contract Research Organizations (CROs)

GCP compliance for clinical trial operations

Regulatory Challenges

  • Multi-site trial coordination
  • eClinical system validation
  • Data integrity in clinical databases
  • Inspection readiness

How We Help

  • GCP training and SOPs
  • CTMS and EDC validation
  • Source data verification
  • Trial master file management
  • Regulatory submission support

Digital Health & SaMD

Software as Medical Device compliance and validation

Regulatory Challenges

  • Evolving regulatory landscape
  • Agile development in regulated environment
  • Cybersecurity requirements
  • Cloud infrastructure validation

How We Help

  • SaMD classification and strategy
  • Agile software validation
  • Cybersecurity assessments
  • Cloud platform validation
  • Mobile app compliance