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Regulatory affairs

Neuvantics is dedicated to providing comprehensive regulatory support to help sponsors navigate complex regulatory landscapes efficiently and bring their products to market in a timely manner. We can provide assistance with regulatory filings such as IND, IDE, NDA, and BLA for drugs, biologics, and medical devices, along with managing interactions with health authorities worldwide throughout the development cycle. Leveraging our extensive experience, we support the planning, preparation, and submission of essential documents, including Institutional Review Board (IRB) and Ethics Committee submissions, to ensure smooth and timely project progression.
We understand the importance of meeting tight timelines and are committed to using our deep regulatory expertise and therapeutic knowledge to accelerate the clinical trial process. Our strong experience with regulatory agencies, IRBs, and Ethics Committees, both in India and internationally, enable us to initiate studies quickly while maintaining strict adherence to regulatory compliance throughout the trial lifecycle.
Our Regulatory affairs services include:

IND/BLA/NDA Development/Submission Services

  • Development of global regulatory strategies for clinical product development
  • Regulatory CMC (Chemistry, Manufacturing, and Controls) consulting
  • Coordination of FDA meetings and communications (pre-IND, EOP, pre-NDA)
  • Assistance with obtaining regulatory designations such as Fast Track, Orphan Drug, and others
  • Preparation and submission of INDs (Investigational New Drugs), IDEs (Investigational Device Exemptions), NDAs (New Drug Applications), BLAs (Biologics License Applications), and 510(k) submissions
  • Preparation of sNDAs (supplemental New Drug Applications) and ANDAs (Abbreviated New Drug Applications)
  • Managing regulatory submissions and interactions with various health authorities through strategic partnerships

Study Regulatory Support

  • Development of recruitment strategies and subject information materials
  • Creation of Informed Consent Forms (ICFs)
  • Vendor assessment and qualification
  • Setup and ongoing maintenance of ClinicalTrials.gov listings
  • Preparation of advertising and promotional content
  • Ongoing documentation upkeep and record reviews