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...
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...
7 Critical Factors for Successful Selection of CDMO for Cell and Gene Therapy Manufacturing
Developing, optimizing, and manufacturing Advanced Therapy Medicinal Products (ATMP's), such as Cell and Gene Therapy (CAGT) products is extremely complex. The choice of a reliable Contract...
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...
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...
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 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’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...
Decentralized Clinical Trials: Changing the Landscape of Clinical Trials
One essential consideration in clinical trial development is whether the trial will represent a given population. The most representative trials use recruitment techniques and advanced statistical...
How to Implement an Effective Audit Trail
Maintaining an audit trail is a regulatory compliance requirement, but what makes an audit trail beneficial for maintaining effectiveness and complying with regulations? This blog will explain what...
How to Ensure Your Workforce is GMP Compliant
As the world tries to get back to some semblance of normalcy after the coronavirus pandemic, pharmaceutical, biotech and med device companies are anticipating the day when the FDA returns to normal...
How to Prepare for the Three Type B Meetings with the FDA
The Food and Drug Administration (FDA) has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND meeting, the second is the End of Phase 2...
How to Understand and Avoid Common Phase 3 Failure Points
By the time the drug development process gets to Phase 3, it seems reasonable to assume that the chance of failure is relatively low. After all, the entire early-development process is at least...
The Unique Challenges of Gaining Approval for Drug-Device Combos
A combination product is composed of any combination of a drug and a device; a biological product and a device, a drug and a biological product, or a drug, device, and a biological product. Consider...
Analytical Methods for the Investigation of Carcinogenic Nitrosamines in APIs and Drug Products
Since September 26, 2019, all EU Marketing Authorization Holders (MAHs) of medicines for human use are facing what might be regarded as a new requirement: review their drug products on the possible...
Why is Process Optimization so Important in Cell and Gene Therapy Product Development?
A recent survey of experts from 145 cell and gene therapy (CAGT) companies revealed the ability to appropriately optimize the manufacturing process as their top concern. Red flags have been raised...