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Visionary Pharma Consulting - Biologics and Pharmaceuticals

Technical consulting services for the biotech and pharmaceuticals industry

http://www.visionarypharmaconsulting.com/

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Technical consulting services for the biotech and pharmaceuticals industry
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Visionary Pharma Consulting - Biologics and Pharmaceuticals | visionarypharmaconsulting.com Reviews

https://visionarypharmaconsulting.com

Technical consulting services for the biotech and pharmaceuticals industry

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Visionary Pharma Consulting - Biologics and Pharmaceuticals

http://www.visionarypharmaconsulting.com/Visionary_Pharma_About_Us.html

Visionary Pharma Consulting LLC. Isionary Pharma Consulting LLC was founded in May 2011 by Anastasia Lolas and is located in Olney, MD. We provide technical consulting services to the biotechnology and pharmaceuticals industry regarding microbial control, sterility assurance and product quality microbiology aspects of regulatory filings as well as cGMP and compliance.

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Visionary Pharma Consulting - Biologics and Pharmaceuticals

http://www.visionarypharmaconsulting.com/Visionary_Publications.html

Visionary Pharma Consulting LLC. A G Lolas, B. Chi, P. F. Hughes, and K. Suvarna. CMC Microbiology Review of Biologics License Applications and Pre-License/Pre-Approval Inspections: Therapeutic Biological Proteins. 2010 American Pharmaceutical Review 2:56-60. A G Lolas and J. W. Metcalfe. Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design. 2011 PDA Journal of Science and Technology 65(1): 63-70. Studies of Microbial Contamination in Biologic Pro. AG Lolas&#...

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Visionary Pharma Consulting - Biologics and Pharmaceuticals

http://www.visionarypharmaconsulting.com/Visionary_Pharma_Home_Page.html

Visionary Pharma Consulting LLC. Visionary Pharma Consulting LLC provides technical guidance and assistance to the pharmaceutical industry regarding regulatory filings and compliance. We offer solutions and recommendations for microbial control, sterility assurance and cGMP aspects with a direct and sincere approach focused on the client. Our experience includes reviewing regulatory submissions for traditional pharmaceuticals and therapeutic biologic products and conducting pre-license and pre-ap...

4

Visionary Pharma Consulting - Biologics and Pharmaceuticals

http://www.visionarypharmaconsulting.com/Visionary_Pharma_Services.html

Visionary Pharma Consulting LLC. Write and review the Chemistry, Manufacturing and Controls (CMC) section or Common Technical Document (CTD) Module 3 of investigational and new drug applications (INDs and NDAs), abbreviated drug applications (ANDAs) and biologics license applications (BLAs). Write and review regulatory meeting package submissions for meetings with the FDA. Provide advice on responses to FDA microbiology information requests and deficiencies. Regulatory Affairs and Compliance.

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Visionary Pharma Consulting LLC. Visionary Pharma Consulting LLC provides technical guidance and assistance to the pharmaceutical industry regarding regulatory filings and compliance. We offer solutions and recommendations for microbial control, sterility assurance and cGMP aspects with a direct and sincere approach focused on the client. Our experience includes reviewing regulatory submissions for traditional pharmaceuticals and therapeutic biologic products and conducting pre-license and pre-ap...

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