EU Regulatory References

EU Regulatory References

EMA–European Medicines Agency EMA Quality Guidelines EMA Biologic Guidelines EudraLex – Volume 3 Scientific guidelines for medicinal products for human use EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines EU Regulatory System EMEA Biologics...
EU Regulatory References

Global GMPs Guidance Documents

US GMPs Background: Overview of US GMPs for Active Pharmaceutical Ingredients (API) References: Code of Federal Regulations (US GMP’s) 21 CFR 58 – Good Labratory Practices for Non-Clinical Laboratory Studies 21 CFR Parts 210 – Current Good Manufacturing...
EU Regulatory References

US Regulatory References

FDA – U.S. Food and Drug Administration Guidance, Compliance: Regulatory Information (Biologics) US BIOLOGIC REGULATIONS The final regulations published in the Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are...

Alex Gibb Joins BioTechLogic as Manager, Analytical Services

(Glenview, IL) July 9, 2013 –  BioTechLogic, Inc., a biopharmaceutical manufacturing and CMC consulting firm, today announced the addition of Alex Gibb to its growing team of technical experts and consultants.  As Manager, Analytical Services, Gibb will support...