Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.

Drug Development 52

Drug Development Clinical Pharmacology Pharmaceutical Companies Pharmaceutical Companies 52

Drug Patent Watch

DECEMBER 10, 2024

They can help ensure that these submissions are complete, accurate, and timely, which is critical for advancing drug development programs. They can help ensure that the commercial pharmaceutical manufacturing process is designed to meet regulatory requirements and offer insight into the most effective manufacturing strategies.

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Documentation Drug Development Pharmaceutical Manufacturing Pharmaceutical Companies 98

Express Pharma

JANUARY 26, 2025

The meeting highlighted the enduring economic and commercial ties between the two nations, with a particular focus on pharmaceutical exports and collaboration in drug development, formulations, vaccines, and Active Pharmaceutical Ingredients (APIs).

Pharmaceutical Manufacturing 82

Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies Vaccines 82

FDA Law Blog: Biosimilars

MARCH 6, 2024

Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Drug Development Pharmaceutical Companies Pharmaceutical Companies 59

Pharmaceutical Technology

SEPTEMBER 14, 2022

Commercial dose companies form a critical component of the pharmaceutical manufacturing industry’s value chain. The dose form manufacturing follows API manufacturing to produce the final dosage form (FDF such as tablets and injectables.

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Dosage Pharmaceutical Manufacturing Documentation Pharmaceutical Companies 40

Pharmaceutical Technology

SEPTEMBER 15, 2022

The pharmaceutical industry requires specialised and cost-effective commercial packaging solutions to improve efficiency and preserve the integrity of products through the entire supply chain, from primary packaging and labelling to shipping, delivery, storage and distribution to end users.

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Packaging Labelling Pharmaceutical Manufacturing Documentation 40

European Pharmaceutical Review

DECEMBER 21, 2022

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Defossilization of pharmaceutical manufacturing.

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Compounding Pharmaceutical Manufacturing Pharmaceutical Companies Pharmaceutical Companies 97