biotechlogic.com
BioTechLogic, Inc - BioPharmaceutical Manufacturing & Consulting ServicesBioPharmaceutical Manufacturing & Consulting Services
http://www.biotechlogic.com/
BioPharmaceutical Manufacturing & Consulting Services
http://www.biotechlogic.com/
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PERFECT PRIVACY, LLC
12808 Gra●●●●●●●●●kway West
Jack●●●●ille , FL, 32258
US
View this contact
PERFECT PRIVACY, LLC
12808 Gra●●●●●●●●●kway West
Jack●●●●ille , FL, 32258
US
View this contact
PERFECT PRIVACY, LLC
12808 Gra●●●●●●●●●kway West
Jack●●●●ille , FL, 32258
US
View this contact
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NETWORK SOLUTIONS, LLC.
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BioTechLogic, Inc - BioPharmaceutical Manufacturing & Consulting Services | biotechlogic.com Reviews
https://biotechlogic.com
BioPharmaceutical Manufacturing & Consulting Services
biotechlogic.com
Clients
http://www.biotechlogic.com/clients
Leadership and Senior Consultants. Our Team of Senior Consultants. Process Development and Quality by Design. Synthesis, Fermentation and Cell Culture Processes. Avecia Biotechnology Inc. (U.S.). Antisoma (U.K.). Astellas Pharma US, Inc. (U.S.). Health Protection Agency (U.K.). A list of case studies is available here. Due to confidentiality not all clients are listed. Bringing Legacy Combination Products into Compliance with 21 CFR Part 4. Ashley Ruth, PhD joins BioTechLogic from FDA. BioTechLogic, Inc&...
Regulatory Submissions Services
http://www.biotechlogic.com/services/regulatory-submissions
Leadership and Senior Consultants. Our Team of Senior Consultants. Process Development and Quality by Design. Synthesis, Fermentation and Cell Culture Processes. BioTechLogic’s regulatory team has supported and prepared global regulatory submissions in the eCTD format. Our experience includes FDA Briefing packages, CTD Module 2 (Quality Overall Summary) and Module 3 (Quality) regulatory submissions for the following products:. Small Molecules (Parenteral Products and Solid Oral Dosage). Preparation and r...
Process Validation Services
http://www.biotechlogic.com/services/process-validation
Leadership and Senior Consultants. Our Team of Senior Consultants. Process Development and Quality by Design. Synthesis, Fermentation and Cell Culture Processes. When the process technology is defined and the manufacturing documentation accurately reflects the developed production steps, the process is ready to move into the Process Qualification Stage. BioTechLogic has expertise in managing all stages of process validation. Process Validation consists of three critical stages:. Stage 1 Process Design.
Reference
http://www.biotechlogic.com/category/reference
Leadership and Senior Consultants. Our Team of Senior Consultants. Process Development and Quality by Design. Synthesis, Fermentation and Cell Culture Processes. Posted on July 21, 2013. EMA European Medicines Agency. EudraLex – Volume 3 Scientific guidelines for medicinal products for human use. EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines. The European Commission (formally the Commission of the European Communities) is the executive branch. Of the European Union. Mandatory for biote...
Synthesis, Fermentation and Cell Culture Process Experience
http://www.biotechlogic.com/experience/synthesis-fermentation-and-cell-culture-processes
Leadership and Senior Consultants. Our Team of Senior Consultants. Process Development and Quality by Design. Synthesis, Fermentation and Cell Culture Processes. Synthesis, Fermentation and Cell Culture Processes. Multiple biopharmaceutical IND filings (cytokines, proteins, antibody fragments) at 10 L to 10,000 L scale. Pre-Qualification activities for an antibody fragment produced at 10,000 L scale. Oligonucleotide Synthesis validation at 100 to 300 mmol in manufacturing. BioTechLogic, Inc., is a bi...
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BioTechLogic, Inc - BioPharmaceutical Manufacturing & Consulting Services
Leadership and Senior Consultants. Our Team of Senior Consultants. Process Development and Quality by Design. Synthesis, Fermentation and Cell Culture Processes. Quickly and successfully augment and optimize your technical, manufacturing, analytical, and regulatory resources with services from BioTechLogic. … [Continue Reading]. Quickly and successfully augment and optimize your technical, manufacturing, … Read More. Request the notes from CASSS CMC Strategy Forum Europe. March 2, 2018. February 21, 2018.
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