Fact Flyers related to GxP Audit
Fact Flyer
Radiopharmaceuticals in diagnostics and therapy form a special product group with specific regulatory requirements in terms of production, distribution, and radiation protection. Necessary safety precautions and often very short half-lives pose special challenges for the business and require a different conceptual approach compared to „conventional“ medicinal products.
Fact Flyer
PharmaLex offers full support along the Validation Lifecycle (VLC) for your New Product Introductions and Technology Transfer projects. Our Validation Professionals are not only validation experts, but process experts. And by this we mean experts in all types of manufacturing processes for all types of dosage forms.
Fact Flyer
PharmaLex offers full support along the Commissioning, Qualification and Validation Lifecycle (VLC) for your new or modified facilities, equipment, and systems. Our Commissioning & Qualification (C&Q) professionals are experienced in each deliverable from the C&Q portion of the VLC; i.e. the V-Model, as established by ASTM E2500 and ISPE‘s GAMP 5.
Fact Flyer
PharmaLex offers regulatory compliance services that address the new FDA requirements that have been implemented to govern the tobacco and vape industry.