End-To-End MES implementation Solutions in Life Sciences
MBR / GMBR / PVL / PMBR / Recipe Design
MES Workshop with Non-Certified training
MES Support on Fit-Gap Analysis (With practical demonstration)
MES System Qualification
CSV Consulting Services
Turbo Projects (Design of Pharma & R&D Setup)
Audit & Compliance
IT-Automation Solution in Life Sciences
Equipment/Instruments Qualification
eCTD (Electronic Common Technical Documents) review and readiness
Dossier Review and readiness Post Approval Support/Submission review and readiness.
Review and Assessment Submitted Regulatory Application (Approved and Pending for
Approval) – ANDA / DMF / IND /NDA for ensuring data integrity and adequacy.
Finding a way to serve you...
Preparation of Standard operating procedure (SOPs)
Supply of Raw materials & excipients
Supply of Cartons
Finished product supply
Process Validation
CSV Consulting Services
Audit & Compliance Management
Inspection Readiness & Support during Regulatory Audits
Supply of Impurities, Solvents & Reference Standards
Review of Bioavailability and Bioequivalence Studies