No longer in business. Provided GLP-compliant preclinical drug development services to pharmaceutical and biologicals industries. Expert in GLP, preclinical CRO selection and management (discovery through manufacturing), auditing, study designs and reports, regulatory submissions (IND/NDA/MAA/BLA), responses and remediation activities related to FDA 483 and Warning Letters (GLP focus), temporary staff replacement (ie. medical leave), scientific and technical writing, GLP-compliant test method development, qualification and/or validation, and animal model development.
Company Details
- Founded
- -
- Address
- Erie, 80516, Us
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Keywords
- GLP compliance, GMP laboratory method assessment, remediation, toxicology study designs and reports, Laboratory method development, validation, scientific and technical writing and regulatory submissions, FDA 483 and Warning Letter responses and remediation.
- HQ
- Erie
- Competitors
Q Questions
Q's LinkedIn profile is https://www.linkedin.com/company/quackenbush-consulting
Q's industry is
Biotechnology Research
Q's categories are Biotechnology Research
Q's founding year is 2010
