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Quality & Compliance

Business & Regulation Standards & Regulation

Five Steps You Won't Want to Miss When Filing an IND

| Sponsored by Regis

What are the most important things to consider when filing an IND? This infographic, sponsored by Regis, sets out the five key steps to success.

Business & Regulation Business Practice

GDUFA 2020

| Stephanie Sutton

GDUFA fees for 2020 have been decided – and include a significant drop in the fees for finished dosage facilities.

Manufacture Bioprocessing - Upstream & Downstream

Trials of a Medicine Maker

Fail to Prepare? Prepare to Fail…

Manufacture Technology and Equipment

Safety in Numbers

| Sladjana Tomic-Skrbic, Gregory Voyta

Viral contamination can shut down a plant for months – affecting manufacturing, causing business disruption and threatening supply and patient safety.

Manufacture Standards & Regulation

Quality, Not Quantity

| Iain Moore

Qualitative risk assessments are a great way to approach quality management and train your operators at the same time.

Manufacture Technology and Equipment

Your Digital Twin

| Stephanie Sutton

By simulating processes in a digital twin of a facility, changes can be safely tested before application in the real world.

Manufacture Bioprocessing - Single Use Systems

Strengthening Supply Chains with MilliporeSigma

| Sponsored by MilliporeSigma

As a leading partner and supplier to the industry, MilliporeSigma continues to strengthen and enhance its supply chain capabilities.

Manufacture Bioprocessing - Upstream & Downstream

Turning up the Heat for Virus Removal (ms)

| Sponsored by MilliporeSigma

Viral contamination can have devastating effects. But innovations upstream can help prevent that.

Manufacture Standards & Regulation

A Continuous Cycle of Success

| David Thompson

Helping to meet demands and reduce shortages... Is continuous manufacturing the way forward for pharma?

Manufacture Ingredients

A Lifetime of Achievement

| Maryam Mahdi

Sitting Down With... David Schoneker, Global Regulatory Director, Strategic Relationships at Colorcon.

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Latest White Papers

Early stage product development using laser diffraction analysis

| Contributed by Malvern Panalytical

Characterization of the size and concentration of liposomes

| Contributed by Malvern Panalytical

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