Regulatory Authorities: Veterinary Medicines
Regulatory Authorities Veterinary Medicines (Regulatory compliance series) In our article on global regulatory authorities for human-use medicinal products,…
Counterfeit Drugs: A Growing Problem
Counterfeit drugs (fake pharmaceuticals and adulterated medicines) are a growing problem around the globe. It is estimated that…
Understanding cGMP Certification
For therapeutic goods to reach patients and consumers, they must be shown to meet Good Manufacturing Practices (GMP)….
Changes to PIC/S GMP
What updates or changes to PIC/S GMP Guidance do you need to understand; and what is the latest version of PIC/S GMP Guidance and PIC/S Annexes?
Medical Device Design
Medical device design should consider – at the earliest of design stages – manufacturing licence application requirements, regulatory compliance requirements, material supply chains and reactivity, and manufacturing at scale.
Are you ‘recall ready’ according to the FDA?
Are you ‘recall ready’? What do regulators such as the FDA, TGA, EMA or MHRA expect in terms of recall preparedness? Recall basics.
Medicine Supply Shortages
Medicine supply shortages relating to the pandemic continue to wreak havoc on treatment continuity. GMP education can help reduce shortages caused by …
Get ready for an Audit
Get ready for an audit (how to train your employees) Need to get ready for an audit? How…
Pharmaceutical Industry Jobs: 5 Essential Skills
What are the requirements for applying for pharmaceutical industry jobs? Are you applying for current Pharmaceutical industry job openings? If…
Software as a Medical Device (SaMD)
FAQs about Software as a Medical Device (SaMD) Medical-purpose software development is a rapidly growing industry. As with…
Industry Updates: PDA and FDA Joint Regulatory Conference
Our GMP courses, e-learning courses and GMP Forums repeatedly get great reviews by people who need to know…
Does my product require FDA approval?
FDA Pre-Approval Requirements Will your product need pre-approval from the FDA before you can sell it to the…
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