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Biotech - Consultant - FDA Regulatory Affairs Biotechnology Consultant

Joanne Bicknese, DVM. Thomas E. Colonna, PhD/JD. Stuart M. Green. Deborah Porter, MA, MS, CCRA. Desencia E. Thomas, MD. Jeffrey W. Schmalz. Jean Xu, MBA. Yihua Yu, PhD. Regulatory Affairs is an integral part of any company looking to successfully sell their biomedical products in today's market. FDA requirements and policies frequently change, drastically affecting the product approval process.". For more information, contact. Dr Thomas E. Colonna. Bear, DE 19701-1306.

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CONTACTS AT BIOTECH-CONSULTANT.COM

Tom Colonna

Tom Colonna

1148 Pul●●●●●●●● 107-342

B●r , DE, 19701

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Tom Colonna

Tom Colonna

1148 Pul●●●●●●●● 107-342

B●r , DE, 19701

US

1.30●●●●2235
1.80●●●●5619
dc●●●@msn.com

View this contact

Tom Colonna

Tom Colonna

1148 Pul●●●●●●●● 107-342

B●r , DE, 19701

US

1.30●●●●2235
1.80●●●●5619
dc●●●@msn.com

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Biotech - Consultant - FDA Regulatory Affairs Biotechnology Consultant | biotech-consultant.com Reviews
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Joanne Bicknese, DVM. Thomas E. Colonna, PhD/JD. Stuart M. Green. Deborah Porter, MA, MS, CCRA. Desencia E. Thomas, MD. Jeffrey W. Schmalz. Jean Xu, MBA. Yihua Yu, PhD. Regulatory Affairs is an integral part of any company looking to successfully sell their biomedical products in today's market. FDA requirements and policies frequently change, drastically affecting the product approval process.. For more information, contact. Dr Thomas E. Colonna. Bear, DE 19701-1306.
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Biotech - Consultant - FDA Regulatory Affairs Biotechnology Consultant | biotech-consultant.com Reviews

https://biotech-consultant.com

Joanne Bicknese, DVM. Thomas E. Colonna, PhD/JD. Stuart M. Green. Deborah Porter, MA, MS, CCRA. Desencia E. Thomas, MD. Jeffrey W. Schmalz. Jean Xu, MBA. Yihua Yu, PhD. Regulatory Affairs is an integral part of any company looking to successfully sell their biomedical products in today's market. FDA requirements and policies frequently change, drastically affecting the product approval process.". For more information, contact. Dr Thomas E. Colonna. Bear, DE 19701-1306.

INTERNAL PAGES

biotech-consultant.com biotech-consultant.com
1

Biotech - Consultant

http://www.biotech-consultant.com/consultants.php

Joanne Bicknese, DVM. Thomas E. Colonna, PhD/JD. Stuart M. Green. Deborah Porter, MA, MS, CCRA. Desencia E. Thomas, MD. Jeffrey W. Schmalz. Jean Xu, MBA. Yihua Yu, PhD. Joanne Bicknese, DVM. Thomas E. Colonna, PhD/JD. Stuart M. Green. Deborah Porter, MA, MS, CCRA. Desencia E. Thomas, MD. Jeffrey W. Schmalz. Jean Xu, MBA. Yihua Yu, PhD.

2

Biotech - Consultant - FDA Regulatory Affairs Biotechnology Consultants

http://www.biotech-consultant.com/publications.php

Joanne Bicknese, DVM. Thomas E. Colonna, PhD/JD. Stuart M. Green. Deborah Porter, MA, MS, CCRA. Desencia E. Thomas, MD. Jeffrey W. Schmalz. Jean Xu, MBA. Yihua Yu, PhD. Colonna, T.E. and Helfgott, J.S. 2009) "Biomedical Software Regulation 1st ed. Washington, DC: FDLI; 2009". Colonna, T.E. and Shapiro, J.K. 2006) "Promotion of Biomedical Products: Regulatory Considerations 1st ed. Washington, DC: FDLI; 2006". Colonna, T.E. Colonna, T.E. Colonna, T.E. Colonna, T.E. Colonna, T.E. Colonna, T.E. 2001) "The H...

3

Biotech - Consultant - Calvin Chue

http://www.biotech-consultant.com/calvinchue.php

Joanne Bicknese, DVM. Thomas E. Colonna, PhD/JD. Stuart M. Green. Deborah Porter, MA, MS, CCRA. Desencia E. Thomas, MD. Jeffrey W. Schmalz. Jean Xu, MBA. Yihua Yu, PhD. Dr Chue provides consulting services. In the scientific and regulatory aspects of a wide range of medical devices and biologics with particular emphasis on rapid detection of pathogenic organisms. Dr. Chue's background is particularly useful to clients. With biomedical products where expertise in biodefense issues is required.

4

Biotech - Consultant - Thomas E. Colonna

http://www.biotech-consultant.com/thomascolonna.php

Joanne Bicknese, DVM. Thomas E. Colonna, PhD/JD. Stuart M. Green. Deborah Porter, MA, MS, CCRA. Desencia E. Thomas, MD. Jeffrey W. Schmalz. Jean Xu, MBA. Yihua Yu, PhD. Thomas E. Colonna. Dr Colonna has a broad educational background with a BS (Microbiology) from the University of Sciences in Philadelphia. Formerly the Philadelphia College of Pharmacy and Science), a PhD (Molecular Biology) from the Johns Hopkins University. And a JD from the Georgetown University Law Center. He has published extensively.

5

Biotech - Consultant - Joanne Bicknese D.V.M

http://www.biotech-consultant.com/joannebicknese.php

Joanne Bicknese, DVM. Thomas E. Colonna, PhD/JD. Stuart M. Green. Deborah Porter, MA, MS, CCRA. Desencia E. Thomas, MD. Jeffrey W. Schmalz. Jean Xu, MBA. Yihua Yu, PhD. Joanne Bicknese D.V.M. Dr Bicknese has a broad educational background with BS and Doctor of Veterinary Medicine degrees from Cornell University. In addition, Dr. Bicknese holds an MS in biomedical writing from the University of Sciences in Philadelphia. Formerly the Philadelphia College of Pharmacy and Science).

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FDA Regulatory Affairs Biotechnology Consultants

http://www.tcolonna.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).

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FDA Regulatory Affairs Biotechnology Consultants

http://www.tcolonna.com/Representative_Publications.htm

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...

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FDA Regulatory Affairs Biotechnology Consultants

http://www.tcolonna.com/Representative_Clients.htm

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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).

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Biotech - Consultant - FDA Regulatory Affairs Biotechnology Consultant

Joanne Bicknese, DVM. Thomas E. Colonna, PhD/JD. Stuart M. Green. Deborah Porter, MA, MS, CCRA. Desencia E. Thomas, MD. Jeffrey W. Schmalz. Jean Xu, MBA. Yihua Yu, PhD. Regulatory Affairs is an integral part of any company looking to successfully sell their biomedical products in today's market. FDA requirements and policies frequently change, drastically affecting the product approval process.". For more information, contact. Dr Thomas E. Colonna. Bear, DE 19701-1306.

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