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Standards & Regulation

Discovery & Development Contract Development Services

Renaissance Man

| Cornell Stamoran

Sitting Down With... Cornell Stamoran, Vice President of Corporate Strategy, Catalent Pharma Solutions, USA.

Business & Regulation Business Practice

Business-in-Brief

| William Aryitey

Record generic approvals, a joint opioid investigation... What’s new for pharma in business?

Business & Regulation Standards & Regulation

Safe Supply Chains for All

| Stephanie Vine

Despite efforts to round up counterfeit criminals, fake medicines still find their way into supply chains.

Manufacture Standards & Regulation

Serialization Blind Spots

| Pavel Lotkov

Serialization is far from simple, and many companies overlook key aspects

Manufacture Standards & Regulation

What’s on the Box?

| William Aryitey

The US and and EU deadlines are approaching, but is the industry ready for serialization?

Manufacture Standards & Regulation

Making Therapeutic History

| William Aryitey

The FDA approval of Kymriah marks the first CAR-T cell-based gene therapy available in the US

Business & Regulation Quality & Compliance

Don’t Touch That Data

| Mark Stevens

Data integrity is an important part of pharma, but not everyone knows how to handle it

Manufacture Standards & Regulation

Putting a Stop to Cell Therapy “Snake Oil”

| Daniel Weiss

We need to stop companies from using loopholes to sell unproven cell therapies to desperate patients

Manufacture Standards & Regulation

Testing the Boundaries

| Sarah James

Are you compliant with the new guidelines for elemental impurities? There’s only six months left to get up to speed.

Business & Regulation Business Practice

Bad Brexit Risks Lives

| James Strachan

Joint letter from eight trade associations warns of “supply disruptions to life-saving medicines.”

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