SERVICES
What we do
AUDITS
Well experienced in conducting various types of audits as per requirements
INTERNAL AUDITS & ASSESSMENT AUDITS (QMS gap analysis)
DOCUMENTATION & DATA REVIEW FOR DATA INTEGRITY ISSUES
MOCK AUDITS (API, Drug product and medical device sites)
DUE DILIGENCE AUDITS (API, Drug product, packaging materials & Excipients sites)
THIRD PARTY AUDITS (As per 21 CFR/ ICH/ EUGMP/PICS requirements)
GCP AUDITS
COMPREHENSIVE TRAINING & WORK SHOPS
Organized 100+ trainings on cGMP and regulatory updates
Trainings on ICH / 21 CFR / EUGMP / PICS guidelines
Trainings on regulatory updates
Trainings on handling of regulatory inspection
Training on data integrity and its importance
CONCEPT DESIGN & GREEN FIELD PROJECTS
Involved in 50+ green projects for concept design review of Green field projects
Concept design for GMP areas
Concept design for Green Field Projects
Monitoring of project status to identify the gaps
Quality by design concept and risk assessment concept implementation from project stage
DMF SUPPORT
Drug Master File (DMF) preparations and submission
DMF preparations and submission for USFDA; CEP etc in CTD format
DMF review for compliance before submission
Support to answer DMF queries from regulatory authorities
Due diligence audit against submitted DMF / CEP to verify the compliance
FREE ESTIMATION
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