thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

Life Science Consulting

December 6, 2022

Changes to the Animal Welfare Act Affecting Animal Research Facilities

Does your organization conduct or outsource testing to an Animal Research Facility? If so, are you aware of the changes that have been implemented to the AWA (Animal Welfare Act) by the Animal and...

Life Science Consulting

October 28, 2022

ProPharma Group's Dr David Crome to Act as Compliance Monitor to the MHRA

From April 2022, the MHRA has been developing a pilot programme for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM) on behalf of companies that have...

FDA CGT

July 13, 2022

7 Critical Factors for Successful Selection of CDMO for Cell and Gene Therapy Manufacturing

Developing, optimising, and manufacturing Advanced Therapy Medicinal Products (ATMP's), such as Cell and Gene Therapy (CGT) products is extremely complex. The choice of a reliable Contract...

Life Science Consulting

June 22, 2022

Project Management isn’t brain surgery, but why is it so hard?

Here is the scenario: you are the leader of a group and you have been given the responsibility of driving the completion of a new initiative, an early or late-stage drug or devices program, or a...

Life Science Consulting

June 13, 2022

What is Product Lifecycle Management and Why is it Critical for Success?

Product Lifecycle Management (PLM) is the process of managing a product from conception through end of of life (EOL), and clearly includes conception (design and development) and commercialization....

Life Science Consulting

April 21, 2022

Annex 21: What You Need to Know

It’s finally here, a guidance on how to handle medicinal products imported from outside EU/EEA. If you’ve ever wondered what the expectations are on these imported medicinal products, you’re in for a...

Clinical Research Solutions Decentralized Clinical Trials

March 2, 2022

Why You Need a Decentralized Clinical Trials Strategy - Before Disaster Strikes

Imagine having your clinical trial ready to go, or already underway, and overnight the brakes are slammed, bringing your trial to a screeching halt. This was the reality for sponsors around the world...

CMC NDA

February 15, 2022

CMC Regulatory Dossier Compliance: A GMP Requirement

Maintaining compliance in the dynamic regulatory Chemistry, Manufacturing and Controls (CMC field can be quite a challenge. A CMC regulatory dossier compliance assessment is a critical component and...

FDA EMA

February 4, 2022

FDA’s Breakthrough Therapy Designation vs PRIority MEdicines (PRIME) Application in Europe

What are Breakthrough Therapy Designation and PRIority MEdicines (PRIME) Applications? The advancement of modern medicine, and the accessibility of researched and regulated medication, has greatly...

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Inspiring the Future of Drug Development

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