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CMC and the Critical Path to NDA: The Journey from Molecule to Market

The Premier Consulting Blog

Bringing a new therapeutic to market is a complex and multifaceted process culminating in submission and approval of a new drug application (NDA). Validation involves detailed documentation of every step of the production process, from raw material sourcing to final product packaging in good manufacturing practice (GMP) compliant facilities.

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The Role of Quality Assurance in Generic Drugs

Drug Patent Watch

From inspecting manufacturing facilities to testing finished products, QA teams work tirelessly to guarantee that every pill, tablet, or capsule that reaches the market is safe and effective. These dedicated individuals play a critical role in ensuring that generic drugs meet the same high standards as their brand-name counterparts.

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BeOne Medicines Gains CHMP Backing for BRUKINSA Tablet Formulation

The Pharma Data

BeOne Medicines Receives Positive CHMP Opinion for New Film-Coated Tablet Formulation of BRUKINSA® (zanubrutinib), Paving the Way for European Market Approval BeOne Medicines Ltd. This dual regulatory progress signals strong global confidence in the new formulation and sets the stage for expanded availability in key markets.

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Article EMA: What will the orphan drug market exclusivity haircut mean for industry?

Agency IQ

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Fill out the form to read the full article.

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Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence

PPD

Challenge #4: Regulatory and market access hurdles The regulatory and health technology assessment (HTA) pathways for rare disease therapies are complex and vary by region. With the new EU HTA Regulation impacting orphan medicines, navigating these pathways has become even more challenging.

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How AI and LLMs are transforming drug discovery: part 1

Drug Target Review

The challenges lie in regulated industries where governance frameworks for standard quantitative models dont necessarily apply to LLMs. The challenges lie in regulated industries where governance frameworks for standard quantitative models don’t necessarily apply to LLMs.

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Elanco’s Zenrelia Wins Positive CVMP Opinion

The Pharma Data

This opinion paves the way for the eventual authorization of Zenrelia for marketing across the European Union (EU) — a crucial step forward in delivering much-needed treatment options for dogs suffering from pruritic skin disorders.