CAL'S GXP Services


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


Additional services:

·         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]

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Page updated 5/28/2012