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FDA Regulatory Affairs Biotechnology Consultants
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Regulatory Affairs Consulting Services. Regulatory Affairs Strategy Development. Investigational Device Exemptions (IDEs). FDA Registered U.S. Agent for Foreign Manufacturers. Training Programs/Seminars/ Distance Education. HIPAA and CFR 21 Part 11 Compliance. Quality Systems Compliance (QSRs, QA/QC, GMPs, SOPs).
tcolonna.com
FDA Regulatory Affairs Biotechnology Consultants
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Alcorn, T.M., Colonna, T.E.,. Green, S.M., Thomulka, K.W., and Campbell, P. (1990) A post growth overlay transforms the conventional nonspecific XP plate assay into one specific for alkaline phosphatase activity J. Microbiological Methods 11: 59-64. Colonna, T.E.,. And Fambrough, D.M. (1997) Subunit interactions in the Na,K- ATPase explored with the Yeast Two-Hybrid system J. Biological Chemistry 272: 12366-12372. Colonna, T.E.,. Hogan, J.M. and Colonna, T.E. Colonna, T.E. and Thomas, D.E. 2001) The Heal...
tcolonna.com
FDA Regulatory Affairs Biotechnology Consultants
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regulatoryaffairswriting.com
FDA Regulatory Affairs Biotechnology Consultants
http://www.regulatoryaffairswriting.com/regulatory_consulting_services.htm
Regulatory Affairs Consulting Services. Regulatory Affairs Strategy Development. Investigational Device Exemptions (IDEs). FDA Registered U.S. Agent for Foreign Manufacturers. Training Programs/Seminars/ Distance Education. HIPAA and CFR 21 Part 11 Compliance. Quality Systems Compliance (QSRs, QA/QC, GMPs, SOPs).