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Overview
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Regulatory Affairs Services Overview

 
Synowledge Regulatory Affairs Services support the timely launch and sustained growth of your products, while ensuring they meet the specified regulatory obligation criteria and are safe for consumer use. Synowledge can help you at every step throughout the regulatory submission process, from inception to market. Our experts have years of experience helping companies achieve the necessary preparation and compliance as required by the FDA, EMEA and other global regulatory bodies. Synowledge can work with you to provide harmonized solutions that will define key milestones for your company with rigid quality checks and SLAs to track all deliverables – while significantly reducing cost and time.

As a competent and trusted partner of regulatory and pharmacovigilance activities, our experts come with broad backgrounds and years of experience helping companies achieve necessary preparation and compliance. With affiliations to international societies such as The Regulatory Affairs Professionals Society (RAPS) and The Organization for Professionals in Regulatory Affairs (TOPRA), your organization will benefit from our in-depth expertise. Our services are customized to fit each one of our client’s requirements; whether you are looking for full-time support or looking to augment and provide support for your current staff, Synowledge can help. With the current ICH scenario and increased global regulatory standards in mind, Synowledge offers the following regulatory and technical services:
 
  • Regulatory Consulting/Support
  • Global Regulatory Submissions – Includes medical devices, medicinal products, Global Clinical Trial applications Phase I to Phase IV
  • Regulatory Medical and Technical Writing
  • Risk Evaluation and Mitigation Strategy (REMS)
  • eCTD Services
  • Strategic Labeling
 
 
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Today's Highlight
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Synowledge is Oracle Gold Partner
 
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Upcoming Events
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Synowledge Webinar Series
 
  Webinar-banner  
  Preparing for E2B (R3)  
  Wednesday 3rd December, 2014
@1pm GMT/ 8am EST/6:30pm IST

 
 
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Call us:
+1 (203) 504 2561
Email us:
info@synowledge.com
 
 
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