Synowledge Announces the Launch of Regulatory Affairs Services
Synowledge's pharmacovigilance compliance assessment measures a company's PV operations against the requirements of all applicable regulatory bodies, reviews company practices across the product lifecycle and recommends improvements.
- (1888PressRelease) July 15, 2011 - Stamford, CT - Synowledge, LLC, a market leader in pharmacovigilance and related IT services for pharmaceutical and biotechnology companies, is pleased to announce the launch of its Regulatory Affairs service line. A key offering in Synowledge's life sciences portfolio, the Regulatory Affairs service line provides clients with full support for the timely launch and sustained growth of their products.
"Our Regulatory Affairs service line was created as a result of many of our clients looking for a partner that can help guide them through the prevailing regulatory climate and the approval process with an emphasis on customization, quality and trust," said David Ingraham, Director of Sales and Marketing at Synowledge. "As a competent and trusted partner of pharmacovigilance activities, Regulatory Affairs is an area that we can further assist our clients and strengthen our partnerships.
Synowledge's Regulatory Affairs services allow clients to focus on core business functions, while ensuring that they achieve the necessary preparation and compliance that their products require. Synowledge provides a comprehensive offering of regulatory and technical services that help clients throughout the approval process, such as:
(1) Regulatory Submissions & Meetings
(2) Operations, QA & QC Support
(3) Compliance Audits & Training
(4) Drug Safety Regulatory Services
(5) Reviewing and Assessing Clinical Protocols
(6) CMC (Chemistry, Manufacturing, Control)
(7) Medical Writing
(8) Life Cycle Management of Recently Marketed Products
(9) Dossier Preparation for Medical Devices
(10) CTD & eCTD
(11) Prepared Summary of Product Characteristic (SmPC), Pack Insert, Product Rationale
(12) Abbreviated New Drug Applications (ANDAs)
About Synowledge
Synowledge is a global provider of drug safety and regulatory affairs services and related IT solutions to small, mid and large size pharmaceutical and biotechnology companies. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to meet all of our clients' needs. With more than 15 years of industry experience, our core team members have worked with leading pharmaceutical, biotech, medical device and health provider organizations. Synowledge headquarters are located in Stamford CT, USA, with additional offices in Columbus, Ohio, the United Kingdom, Germany, and India. For more information, please visit www.synowledge.com.
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