CAL'S GXP Services
· Provide following specialized GXP services:
o GMP (Good Manufacturing Practices) –
§ Consent Decrees Remediation
§ Effective and efficient responses to FDA Form 483 and Warning Letters
§ Quality Systems
§ CAPA analysis and improvement
§ Deviations Investigation and report
§ Change Control Management
§ GMP audits and monitoring
§ FDA PAI (pre-approval Inspection) preparation and readiness
o GCP (Good Clinical Practices) –
§ GCP audit at clinical sites (especially in China)
§ GCP site monitoring
§ GCP audits on CRO and Investigators
o GLP (Good Laboratories Practices) –
§ Arrange GLP pre-clinical studies
§ Arrange Bio-analytical Lab services
o GDP (Good Distribution Services) –
§ Arrange global IVRS and Depot services
§ GMP/GDP audits on Depots
· Serves as US Agent for DMF (Drug Master File) and electronic filing of Drug Product Registration and Label Code (eDRLS)
· Provide Electronic Gateway for eIND and eNDA and eANDA
· Compile DMF (especially, translation from Chinese to English) and submit DMF to US FDA
· Bridge the trade of ANDA (from US to China) and then provide consultation and assistance in establishing Quality Systems and GMP Commissions, Technology Transfer, Manufacturing Site change and Regulatory Filing
· Assist New Chemical Entity (NCE) clinical studies, IND and NDA
· Free scientific and regulatory advices to Board Directors of start-up virtual pharmaceutical and biotech companies.
· Clinical Supplies/Distribution Consultation.
· CMO and CRO evaluation and recommendation for global clinical studies.
· Foreign vendors’ cGMP audits and provide as “Outside Inspectors” reports to US FDA.
For more information email: Lee999888 [at] gmail.com
Thank you for visiting www.cals-gxp-services.com
Page updated 5/28/2012