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Why Us
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Our service based on regulatory services
- 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.
- Preparation of Standard operating procedure (SOPs)
- Supply of Raw materials & excipients
- Supply of Cartons
- Finished product supply
- Process Validation
- Audit & Compliance Management
- Inspection Readiness & Support during Regulatory Audits
- Supply of Impurities, Solvents & Reference Standards
- Review of Bioavailability and Bioequivalence Studies
- Review of BE-BA reports
- Review of Pharmacokinetics Studies
- Pharma Consultancy
- Product Risk Assessment
- Supply of Safety Aids
- Training
- Recruitment