Validation, Laboratory, Quality Assurance services and Laboratory Consumables

Validation Life Cycle Management

Supporting business in validation of Pharmaceutical facilities including Manufacturing and Laboratory Area and compliance for optimal performance.

Qualification of utilities (Water for Injection, Purified Water, Clean Steam, Compressed air and Natural gas. IQ, OQ and PQ to include environmental monitoring, Air balancing assessment, Temperature, Humidity and Differential pressure assessment, and Recovery studies.

Qualification of Facilities (Clean Rooms (Sterile and Non-Sterile) including classified Grade A/B/C/D, CNC rooms, Sampling Booths, Biosafety/ Laminar Hoods)

Qualification (IOQ and Mapping studies) for Controlled Temperature (Stability chambers, refrigerator and Freezers)

Qualification of Controlled Warehouse (IQ, OQ, PQ to include empty and full load, seasonal mapping)

Analytical and Quality Control Services

Expert scientific consulting to establish compliant facilities and processes for Laboratory.

Analytical/QC Instrument Qualifications (IOQPQ for Scales, pH meter, Friability, Osmometer, Disintegration, Dissolution, HPLC, UPLC, GC, Particle size)

Method Development, Method Validation and Method verifications

Method Transfer and method equivalency.

Compendial method evaluations.

Laboratory Setup including training & qualification, SOP’s, EOP’s, Deviations (OOS, OOT) & Internal Audit

Quality Assurance Services

Expert support for Quality and compliance tailored to your business needs.

Quality Management System (QMS) Support

Deviation including OOS & OOT and Root Cause Analysis / Corrective and Preventive Action

Data Integrity and 21CFR Part 11 Assessments.

cGMP and Process Gap Assessments

SOP creation & Training Program Development

Auditing (GxP Systems) & Support for audit remediation

Laboratory Supplies

Pharmaceutical and laboratory consumable supplies for Pharmaceutical, Industrial and academic laboratories.

Glassware (Volumetric flasks, Pipettes, Beakers)

HPLC vials & GC Vials

Filters (Mobile Phase, Nylon, PVDF & PTFE syringe filters)

HPLC Columns

Impurity Standards (Partner with Reputed company) including characterization reports

Laboratory consumables used for Chromatographic methods