Regulatory

EU GMP Annex 1

EU GMP Annex 1 – Sterile Manufacturing Requirements and Controls

Contamination, Manufacturing, Regulatory

Declaration of the objectives and scope of the European Biotech Act

EU Biotech Act Ignites a New Wave of Biologics Partnerships

Biologics, Clinical trials, EMA, Regulatory

Navigating regulatory approval of biologics: A guide for emerging biotechs Bringing a biologic to market is an increasingly complex task, especially for small and mid-sized biotech companies with limited regulatory infrastructure. Meeting sometimes divergent EMA and FDA expectations, following increasingly complex regulations, and avoiding pitfalls related to documentation requires early planning and cooperation. Cross-functional alignment is also crucial to avoid issues related to comparability and process development/design space/process validation. This whitepaper outlines the key considerations in regulatory planning and biologics development, offering actionable insights for sponsors preparing their therapies for market. Bringing a biologic to market is a complex task, but with strategic planning and the right partners, emerging biotechs can overcome the regulatory hurdles with confidence. Mabion’s deep understanding of both EU and US regulatory requirements, coupled with extensive hands-on experience in biologics development and manufacturing, positions us as an ideal partner for companies seeking to streamline their path to approval.

Navigating Regulatory Approval of Biologics: A Guide for Emerging Biotechs

EMA, FDA, GMP, Regulatory

biofilm risks in water systems

Risk Management Strategies for Biofilms in Water Systems used in Sterile Drug Manufacturing

Contamination, Regulatory

The New Era of Biosimilar Development: Seizing the Opportunity Under EMA’s Streamlined Guidelines

Biosimilars, Clinical trials, Drug development, EMA, FDA, Mabion, Regulatory

oox results

Navigating OOX Results: Effective Analysis and Management in CDMO Laboratories

Analytics, Manufacturing, Regulatory

Biologics drugs to be approved in 2024.

Top 5 most expected biologics in 2024

Biologics, Drug development, EMA, FDA, Regulatory

EMA and FDA

Similar but not the same: an in-depth look at the differences between EMA and FDA

Biologics, EMA, FDA, Regulatory

EU Pharma Law Reform

Revolution in the EU pharmaceutical legislation ahead

EMA, Regulatory