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Pharmalytik is an analytical external services provider. Our goal is to provide high quality technical support to the pharmaceutical industry in various analytical functions within client directives and timelines. Our training program is customized and delivered with the same quality that is being offered at many national scientific meetings.

Pharmalytik is an independent private company found in 2002. It is where quality services are delivered with pride.



 Consulting 


Pharmalytik provides consulting services in the cGMP and analytical areas for pharmaceutical industry in the past 8 years.


Projects include assessment of validation, evaluation of GMP system, CMC reviews, regulatory submission strategies, stability studies, OOS investigations.


Services may be requested by email to Info@Pharmalytik.com.




 CRO Management 


Pharmalytik provides project management oversight for activities conducted worldwide. Projects include Stability Testing, Method Transfer, Method Validation, CMC documentation, and GMP evaluation.


This is a cost-effective way to manage your CROs and allow your analysts to work on more critical projects.


Services may be requested by email to Info@Pharmalytik.com.


 cGMP Training 


Pharmalytik provides technical training in the Pharmaceutical area since 2001. Courses are available to be delivered at your site or customized to fit your needs. Interactive training program is designed for group of 5 to 20 participants.


Trainings may be requested by email to Info@Pharmalytik.com.



 On-Site Courses 


Pharmalytik provides full on-site GMP trainings. Objectives and Materials will be delivered and customized to equip your staff with relevant knowledge to enhance productivity. Exercises and quizzes will be built in for training evaluation purposes.


Courses may be requested by email to Info@Pharmalytik.com.



Founder & Executive Director


Kim Huynh-Ba has almost 25 years of experiences in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on quality and compliance activities since 2003. Her clients are from various sizes of pharmaceutical companies in US and abroad. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide.


Kim Huynh-Ba has 10-year experiences teaching a wide range of adults globally using traditional and eLearning formats. She provides training national and international organizations. She is also an adjunct faculty of Pharmaceutical Analysis course for Temple University, School of Pharmacy and Illinois Institute of Technology. She also taught General Chemistry for Widener University.


Kim Huynh-Ba is a recipient of the 2008 Service Award of Analysis and Pharmaceutical Quality Section and 2008 Recognition Award of Regulatory Section of AAPS. She also received the 2001 DuPont Pharmaceutical Company Asian American Leadership Award.


Kim Huynh-Ba has authored numerous technical publications and book chapters and has spoken extensively, both domestic and internationally, of the compliance and quality areas. She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010).


Save on time!  Save on travel!  Same Quality!

Highlights

  • Coming soon.

"Introduction of Pharmaceutical Analysis"

Expected in September 2016,
John Wiley & Sons Publisher.

by K. Huynh-Ba (ed.)



Pharmaceutical Stability Testing to Support Global Markets

February 2010,
Springer Publisher & AAPS.

by K. Huynh-Ba (ed.)



"Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices"

November 2008,
Springer Publisher.

by K. Huynh-Ba (ed.)


Contact Info



Pharmalytik

Newark, DE USA


info@pharmalytik.com


(302) 731-9959