Offshore Capabilities

For customers looking for offshore resources, Syner-G also offers CMC solution provider services based in India. Working with Eastern assets can provide the customer with cost advantages while still delivering high quality work. Syner-G’s operations in India follow the same CMC 360™ model used in the West, further differentiating us from typical CMC consultants.

Capabilities in CMC & Regulatory:

  • Resources in multiple global locations, seamlessly guided and managed by the US office
  • Highly skilled group of professionals
  • Tactical CMC and regulatory affairs solutions
  • eCTD documentation submissions
  • DMFs
  • Post-approval changes
  • Life cycle management
  • Annual reports
  • All aspects in execution of various CMC strategies
  • Computer system validation services

Capabilities in Remote Research Management:

  • On-site project management of outsourced projects at CDMO sites by well qualified and experienced domain experts
  • “Person in Plant” services by our India-based experts
  • Assistance with process chemistry, GMP scale-up and CMC documentation review by India resources, guided by US domain experts
  • Transparent and professional technical reports
  • Facilitate compliance, data integrity, and quality
  • Responsible supply of KSMs/intermediates/drug substance under close supervision at select CROs
  • Facility audits, capability assessment, regulatory, and EHS audits

Capabilities in QA & Compliance Management:

  • QA audits of off-shore manufacturing facilities
  • QA “Person in Plant” services by our India-based experts
  • EHS audits
  • QA review CMC documentation
  • Facilitate compliance, data integrity and quality
  • Pre-approval inspection readiness/support
  • Computer system validation services


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