CAL'S GXP Services

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.

CAL'S GXP Services

CAL'S GXP Services

Services

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