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Global Regulatory Services 

Regulatory Affairs plays a pivotal role in navigating complex compliance requirements, ensuring product safety, and facilitating market access. Trinity M Consulting offers expert guidance and support to streamline regulatory processes, optimize submissions, and navigate evolving regulations, empowering clients to achieve successful product launches and maintain regulatory compliance. 

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1

Regulatory Strategy

  • Regulatory Pathways Analysis.

  • Regulatory Strategy.

  • Industry Guidance and Trainings.

  • Regulatory Market Access. 

2

Regulatory Information Management

  • Support with Regulatory Data (Pre-market, Market Access, and Post-market). 

  • Support with Regulatory Project Management, Data Trending, and Tracking.

  • Regulatory Submission Management.

3

Regulatory Submission Services 

  • Regulatory Submissions Prep (Q-sub).

  • Regulatory Submissions (510(k)sPMAs, â€‹NDAs, INDs, De Novo, EU MDR, UKCA). 

  • Breakthrough Designations.

  • Technical Documentation Remediation Support. 

  • Market Registrations (India, EMEA, UK, Canada, LATAM, APAC, ROW).

 

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