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QA * QC * GMP * GLP * GCP * Regulatory * Analytics * Validation * * Product Development * Project Management *

BTK Serves the Pharmaceutical, Biotech and Devices. Industries at all Stages of Product Development. QA * QC * GMP * GLP * GCP * Regulatory * Analytics * Validation * * Product Development * Project Management *.

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QA * QC * GMP * GLP * GCP * Regulatory * Analytics * Validation * * Product Development * Project Management * | bioteknowledge.biz Reviews
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QA * QC * GMP * GLP * GCP * Regulatory * Analytics * Validation * * Product Development * Project Management * | bioteknowledge.biz Reviews

https://bioteknowledge.biz

BTK Serves the Pharmaceutical, Biotech and Devices. Industries at all Stages of Product Development. QA * QC * GMP * GLP * GCP * Regulatory * Analytics * Validation * * Product Development * Project Management *.

INTERNAL PAGES

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1

BTK is an international company, helping our clients with U.S. FDA and European EMA, and OECD GLP, cGMP and GCP regulatory compliance. We enable them to manufacture and market their products worldwide. Recent projects have helped clients in China, Singapor

http://www.bioteknowledge.biz/Asia.html

Please contact us to discuss your needs in China and the Asian market:. We are your Asia connection.

2

Our Clients

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Here are only a few of the clients or contractors we have worked with:.

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Managed client’s GMP manufacturing sitePreparation and hosting of regulatory inspectionsObtained OECD GLP compliance certification for Singapore client Assisted client with remediation of GMP systems as per FDA warning latterDevelopment of biosimilar produ

http://www.bioteknowledge.biz/Projects.html

Managed client’s GMP manufacturing site. Preparation and hosting of regulatory inspections. Obtained OECD GLP compliance certification for Singapore client. Assisted client with remediation of GMP systems as per FDA warning latter. Development of biosimilar products. First GLP validation of a gene expression assay for clinical trail support. Resolved 483 Issues Leading to a successful client PAI (medical device). Established and managed QA/QC departments. Conducted due diligence audits.

4

In general, protein structure depends on the manufacturing process. Proteins derived from prokaryotic (bacterial) cells can be improperly folded, lacking glycosylation and are not secreted. Eukaryotic cells can fold proteins properly, but they can introduc

http://www.bioteknowledge.biz/Biosimilars.html

In general, protein structure depends on the manufacturing process. Proteins derived from prokaryotic (bacterial) cells can be improperly folded, lacking glycosylation and are not secreted. Eukaryotic cells can fold proteins properly, but they can introduce variations in carbohydrate structure and other post-translational modifications. BTK Consultants have been involved in the development of new biologics by recombinant DNA technology since the early days of the industry. They have the development, ...

5

Experience

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Bioteknowledge Consultants have held executive management positions at many Fortune 500 Pharma and Biotech Companies and the Food and Drug Administration. They have experience shepherding the drug development process from R&D through clinical trials and on to post-licensing and marketing. Our professionals belong to many scientific and professional societies, including:. Regulatory Affairs and Professional Society (RAPS). American Association for the Advancement of Science. New York Academy of Sciences.

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QA * QC * GMP * GLP * GCP * Regulatory * Analytics * Validation * * Product Development * Project Management *

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