Infill Life Science

Pharmaceutical / Biopharmaceutical Regulatory Affairs

Infill team has extensive experience in preparing, reviewing, submitting INDs, ANDAs, MAAs in CTD / eCTD formats and getting approval of drug products from various Health Authorities (US FDA, EU and others). The team is also well experienced in the preparation, review, submission and approval of DMFs (CTD/eCTD formats) from Health Authorities (US FDA, EDQM, EU and others) for global markets.

The team has prepared meeting requests, packages and had face-to-face meetings (Pre-ANDA, Pre-IND, EOP, and GMP) with US FDA. Also had multiple telephonic meetings with various Health Authorities (US FDA, EMA, and MHRA).

I-Regulatory Services includes

    1. Support in the preparation of meeting request
    2. Briefing Package / Scientific Advice
    3. Controlled Correspondence
    4. Pre-ANDA meetings

Regulatory Services for Market Authorization

  • IND/IMPD compilation: Regulatory document preparation
  • DMF/ASMF/CEP: Submission of regulatory files
  • NDA/ANDA/MAA: Regulatory approval applications
  • e-CTD Submissions: Standardized electronic submissions
  • Deficiency Response: Addressing regulatory deficiencies

Life Cycle Management

  • Prior Approval Supplement
  • Changes Being Effective (CBE-30/CBE-0)
  • Variations

Labeling/SPL Services

  • Artwork services & solutions
  • Designing/review of labeling–Container label/carton/Package Insert
  • NDC listing/Labeling updates
  • NDC Labeler code Request
  • Facility Establishment Identifier (Initial Request/Annual Update)
  • SPL-Structured Product Labeling

Medical Device Support

  • Combination Drug Product (Drug + Device)
  • Facilitate in designing of Device Design History File
  • MDMA for SFDA
  • Comparative Threshold Analyses (as per US FDA requirements)