Synowledge, LLC

Synowledge is a global provider of drug safety, regulatory affairs and related IT solutions to small, mid and large sized pharmaceutical, biotechnology and medical device companies. Our experts come with years of experience developing innovative and highly-customizable solutions for drug safety and regulatory affairs management. Synowledge’s comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to help meet all of our clients’ needs and support the sustained growth of their products.

Synowledge is headquartered in Stamford, CT, USA with operational facilities located in Ohio, the United Kingdom, Germany, and India. For more information, please visit www.synowledge.com
Synowledge’s portfolio includes:

• Drug Safety Services
o AE Case Management
o Medical Literature Review
o PV Regulatory Compliance Consulting
o Aggregate Report Writing
o PV Risk Management Services
o Signal Detection
o Medical Information Call Center Services
o QPPV Provision

• Regulatory Affairs Services
o Regulatory Consulting / Support
o Global Submissions
o Regulatory medical and Technical Writing
o Risk Management (RMP/REMS)
o eCTD Services
o Strategic Labeling Services

• IT Services
o 24/7/365 Safety Database Application Support
o Release and Change Management
o Safety Database Administration
o User and Configuration management
o Query and Report Development and Deployment
o Dictionary Management
o Disaster Recovery