Regulatory Strategy & Services

Regulatory Strategy & Services

At Azzur Group, we partner with leading pharmaceutical, biotechnology, and medical device companies to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations.

At Azzur Group, we partner with leading pharmaceutical, biotechnology, and medical device companies to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations.

  • Authoring and reviewing regulatory documentation for IBs, INDs, ANDAs, NDAs, DMFs, BLAs, CPPs, IDEs, De Novas, 510(k)s, and PMAs
  • Advising on regulatory interactions with FDA and other international agencies, including expedited programs such as INTERACT, RMAT, Breakthrough, and Fast Track
  • Consulting on pharmacology, toxicology pharmacokinetics, and ADME
  • Support lifecycle management of regulatory submissions of amendments, supplements, annual reports, DSURs, and PADERs
  • Prepare regulatory meeting requests and requisite briefing packages
  • Provide strategy and support with drug listings and facility registration
  • Provide strategy and support with EPA medical device registration
  • Global eCTD publishing
  • Former FDA Consultants
  • Inspectional readiness programs
  • ISO 13485:2016 certification readiness program
  • GLP, GCP, GTP, and GMP Expertise
  • Import Export regulatory logistic services
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