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Development, Design and Prototype Stage
Pre-clinical and Clinical Development
Regulatory Clearance and Approval
Postmarket Activities
You have successfully entered the marketplace, but the environment is constantly changing and your ability to maintain product viability is regularly challenged. Perhaps you are planning to expand your marketing, improvise on your product, its labelling or instructions. You may be concerned about successfully managing your postmarket surveillance efforts. Synergia Bio Sciences can help you to plan and manage all of these challenges. Our professionals have the knowledge and expertise necessary to help you to:

Perform EU Vigilance Reporting
Respond to FDA 483s and Warning Letters
Develop effective and competitive regulatory strategies to address future product and labelling changes
Prepare Traditional or Special 510(k) submissions for new products or existing product modifications
Assess and understand any applicable regulations and individual country requirements to support international market launches
Design, manage, and monitor any clinical studies you may need to support future submissions or to meet any post-market requirements
Prepare your team for regulatory inspections or Notified Body assessments
Manage your post-marketing surveillance requirements, include complaint handling, medical device reporting (MDR), vigilance reporting, failure investigations, problem reporting and device tracking
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