Regulatory Affairs
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Regulatory Support
Our team have a broad range of expertise to support every step of product regulatory requirements.
We work with each client to understand the need and provide a customized solutions based approach. Our team is qualified to assist with every stage of product lifecycle.
Regulatory Compliance
Our consultants are experienced in the field. We have worked with a broad range of medical devices and developed numerous of compliance documents to help with bringing products to market and maintaining compliance.
Market Access
If you are looking to bring products to market in the United States, Europe, or Latin America, we have the expertise to help. We will help you analyze and outline the best market access regulatory strategy.
Our consultants are skilled professionals with experience in:
- FDA Pre-Submission (Q-sub)
- 510(k)s
- Post Market Approval (PMAs)
- New Drug Applications (NDAs)
- Investigational New Drug (IND) Application
- EU MDR and UKCA Submissions
- Technical Documentation
- Market registration support (India, EMEA, UK, Canada, LATAM, APAC)
- EU Representative
- Person Responsible for Regulatory Compliance
