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
Headquarters
100 Pennsylvania Avenue, Suite 310
Framingham, MA 01701
Contact Us
508.460.9700
info@synergbiopharma.com