Global Quality & Compliance Consulting Services
Experienced GCP compliance consultants providing a wide range of GCP QA services, such as:
Internal GCP QA resources supporting internal and external clinical teams with GCP direction and guidance
-Implement study-specific quality plans
-Partner with clinical management to conduct gap assessment or identify quality system
improvements opportunities
-CAPA support and management
-Inspection readiness and support prior to, during and post inspection activities
-Partner with IT/IS for electronic systems (eTMF, EDMS, Audit, CAPA) implementation
External audits:
-Clinical Investigator research sites, including inspection readiness and support
-CROs, Vendors, clinical labs, bioanalytical labs, IRBs
-Internal audits:
-Clinical Processes/sytems (TMF, Clinical processes, DM, IMP)
-Documents, eg. CSR, ISS, ISE, PV related, eg. PSMF
-Quality Systems (Policy, SOP, WPs) review, development and management
-Training for clinical research sites staff on regulatory Inspections and GCP / ICH
Company Details
- Employees
- 4
- Founded
- -
- Address
- The Gxp Group, Mountainside,nj 07092,united States
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- HQ
- Mountainside, NJ
The Gxp Group, Llc Questions
The Gxp Group, Llc's LinkedIn profile is https://www.linkedin.com/company/the-gxp-group-llc
The Gxp Group, Llc has
4 employees.
View email and phone details for 4
employees at The Gxp Group, Llc.
The Gxp Group, Llc's industry is
Biotechnology Research
The Gxp Group, Llc's top competitors are
Gxp Cellators Consultants Ltd.,
Engage Group,
Absincgroup,
Gxp Consulting Group, Inc,
Jgb Biopharma Consulting Inc.,
Auger-Domínguez Ventures,
Development Insights,
Venetas Vaccine Consultants Ltd,
Synergy Biotech,
Avoca, A Wcg Company.
The Gxp Group, Llc's categories are Biotechnology Research
The Gxp Group, Llc's founding year is 2017
