Discovery and  Preclinical Research 

Early research and development activities in a drug or device development program can make or break a product. The proper documentation of early studies, whether performed at the bench, in vivo or in vitro, is critical to the successful commercialization of a drug product or device. Best practices and regulations in the preclinical arena have led to significant improvements in reproducability. Our consultants understand the unique issues that can arise later in development when early studies have not been designed or documented adequately. GXPQS consultants are well-versed in GLP and GDP and can assist clients in developing robust reports and documentation systems for early stage research.

Services:

  • Development of preclinical research model and dosing (non GLP)

  • Project management and vendor oversight of GLP testing facilities and/or other vendors

  • GLP qualification, routine and for-cause audits of GLP animal testing facilities, specialty and bioanalytical testing laboratories, and final study reports

  • Routine and ad-hoc ISO 9001 audits of preclinical animal testing facilities, vendors, and suppliers 

  • Gap analysis of preclinical development plan and risk-analysis and mitigation planning

  • Preclinical protocol and final report preparation and assessment and/or QA review and approval.

  • Preparation, assessment and/or review of pharmacology/toxicology and pharmacokinetics animal and human) sections of documents and regulatory submissions (i.e. INDs, NDAs, BLA’s, DSURs, IBs, SPAs, Amendments to Modules 2 and 4, etc.).

Contact Us

(713)-882-1987

info@gxpqsllc.com

8000 Research Forest Drive Ste.115-32 

The Woodlands, Texas 77382