Business Imperatives

  • A Switzerland-based biopharmaceutical company needed Regulatory support for a monoclonal antibody BLA submission in Brazil.
  • The client aimed to ensure alignment with ANVISA requirements, address documentation gaps, and validate the cold chain transportation process.

Objectives

 

To enable a smooth BLA submission for a monoclonal antibody product in Brazil by addressing Regulatory variability, aligning documentation with ANVISA standards, and ensuring successful GMP certification and cold chain validation.

 

Problem Statement

  • Regulatory variability and evolving ANVISA requirements made documentation review and alignment challenging.
  • Cold chain transportation validation required country-specific compliance.
  • Existing GMP certification processes needed review and verification for acceptance by ANVISA.

Freyr Solutions and Services

Freyr Solutions and Services

Freyr provided complete Regulatory support, starting with a detailed gap analysis of the documentation.

The team scheduled and participated in the pre-submission meeting with ANVISA, supported the development and validation of the transport chain, and helped in reviewing the GMP certification already submitted by the client, including direct liaison with ANVISA to verify its status.

  • Full compliance with ANVISA requirements
  • Cost and time savings through early identification of gaps
  • Improved approval likelihood by validating the end-to-end transport chain
  • Progression and potential approval of GMP certification, avoiding resubmission
  • Regulatory process optimization for Brazilian market entry

Freyr ensured Regulatory alignment, streamlined the submission, and facilitated progression through ANVISA’s GMP certification review. This reduced the time to market and increased the likelihood of approval.