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Halo Launches Sterile Fill-Finish: GMP Qualification Becomes Its Next FDA Milestone

Halo Pharma is preparing to launch a new sterile fill-finish platform in the United States, marking its first move into syringe, vial, and cartridge filling. The expansion responds to demand for domestic injectable capacity, while the Apotex partnership gives Halo
  • News
Halo Launches Sterile Fill-Finish: GMP Qualification Becomes Its Next FDA Milestone

FDA Medical Devices Registration in 2026: 510(k), Device Listing, and Compliance Guide

Learn how FDA device registration and listing connects with classification, product codes, 510(k) pathways, FURLS records, annual renewal, and inspection readiness. The guide also explains common data gaps that can delay imports or threaten U.S. market access.
  • Blog, Medical Devices
Medical device compliance dashboard showing FDA medical device classification, product codes, FURLS device registration, 510(k) records, import checks, and establishment listing controls.

Regulatory Compliance Consulting in 2026: FDA, EMA, and Regulatory Affairs

Discover how pharmaceutical regulatory consulting helps organizations eliminate common GMP compliance gaps, improve FDA Compliance and EMA Compliance, implement ICH Guidelines, strengthen regulatory strategy, and achieve greater inspection readiness for successful global market authorization.
  • Blog, Quality Management System
Infographic illustrating common GMP inspection gaps, including documentation, CAPA, data integrity, change control, and risk management that support regulatory consulting services, FDA Compliance, EMA Compliance, and ICH Guidelines.

Why Inspection Readiness Is Becoming Harder; Digital GMP Raises New Risks

In a recent interview with Christopher Cole of Pharmaceutical Technology, Henrik Johanning from Epista Life Science discussed how pharmaceutical manufacturing and regulatory systems in Europe are shifting from 2025 into 2026. He explained that quality risk management, digital GMP, and
  • News
Why Inspection Readiness Is Becoming Harder; Digital GMP Raises New Risks