- FDA Guideline On General Principles Of Process Validation
- WHO Supplementary Training Modules: Validation, Water, Air Handling Systems
- FDA’s Process Validation Guidance
- EMEA Process Validation
- ICH Q7: GMP’s for API’s
- PDA Technical Report #42 : Process Validation of Protein Manufacturing
- Sterile Drug Products Produced by Aseptic Process: GMP’s
- Annex 15: EU Guidance Qualification and Validation (Medicinal Products)
- ICH Q8: Pharmaceutical Development
BioTechLogic, Inc., is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization's technical, manufacturing, analytical, and regulatory resources.
Top 25 Biotech Companies of 2024
Article originally published on GEN The biotechnology industry achieved many firsts this past year, from the first approved drug that can slow the rates of cognitive and functional decline in adults with Alzheimer’s disease, to the first CRISPR-based gene editing...
The EU Clinical Trials Regulation – Experiences from the First 18 Months
Originally posted on Regulatory Focus - a RAPS publication The new EU Clinical Trials Regulation represents the most significant overhaul of clinical trial requirements in Europe for a generation, and this article describes the insight gained during the months...
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