life science consulting

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Quality & Compliance

Demystifying CAPA Management: Overcoming Challenges in the Fast-Paced World of GMP

This article has been updated since its original publication date. Navigating the complexities of Corrective Action / Preventive Action (CAPA) in the drug and medical device industries often poses a...

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Clinical Research Solutions

Clinical Trial Good Clinical Practice (GCP) Audits – Are you ready?

This article has been updated since it's original publication date. Good clinical practice (GCP) is an international ethical analysis and scientific quality standard for designing, conducting, and...

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Clinical Research Solutions

The Importance of Responding to FDA 483 Observations

This article has been updated since its original publication date. The FDA has an established policy that allows companies 15 days to respond in writing to the FDA after issuance of a 483...

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Clinical Research Solutions

FDA Form 483: Common Pitfalls You Can Avoid

This article has been updated since its original publication date. FDA Form 483 requires a written response in which you must make it clear that you are taking the observations, and your...

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Quality & Compliance

15 Days of Panic: You Received FDA Form 483 Warning Letter, Now What?

This article has been updated since its original publication date. Remember the last time you were pulled over by the police? Maybe you had a taillight out. Perhaps you were speeding. You may have...

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Clinical Research Solutions

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...

Clinical Research Solutions

Be Careful What You Ask For (Prior to Consent)

According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical...

David Crome

Clinical Research Solutions

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...

Clinical Research Solutions

Your Vendor Audit Program: On-site or Remote / Virtual?

It is quite common that a sponsor company will outsource services to external vendors, whether for additional expertise, remote locations, or simply due to lack of availability of resources within...

Clinical Research Solutions

Clinical (IMP) Drug Supply…It’s Complicated

Things to consider and how to ease the process IMP Supply Management is a journey where GMP meets GCP and GDP. This journey includes finance, flow of products and documentation. How a company manages...

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