WHAT WE OFFER
Human Plasma Infrastructure & Testing Solutions
- Blood Banks & Apheresis Center Setup
- Fresh Frozen Plasma (FFP) Bank
- Plasma Qualification & Testing Laboratories (NAT, ELISA, QC & QA)
- Pooled Plasma Lab Setup for Fractionation Input
Global Regulatory Compliance
- US-FDA 21 CFR Part 11 (Data Integrity & E-Records)
- EU-GMP, UK-MHRA, WHO-GMP, PICS Standards
- Validation Support – IQ/OQ/PQ, Cleaning, HVAC, Equipment
- Tech Transfer, SOPs, Dossier & CTD Preparation
CRO/CMO Services
- Biological CRO Labs for R&D, Stability, and Validation
- CMO Facilities for Injectable Drugs & Bio-Ingredients
- End-to-End Batch Documentation & Compliance.
Plasma-Derived Medicinal Products (PDMPs)
- Albumin
- Immunoglobulins (IVIG)
- Hyperimmune Globulins.
Modern Plasma Fractionation Technologies
- Chromatography-Based Plasma Fractionation
- Viral Inactivation Systems
- Closed-Loop Automation Systems
Biopharma & Biological Products
- Monoclonal Antibodies (MAbs) – R&D and Production
- Biosimilars & Recombinant Therapeutics
- Critical Care Injectables & Vaccines
- Fill-Finish Injectable Units
Bio-Products & Nutraceutical Ingredients
- Probiotics (Single and Multi-Strain) – Liquid & Powder
- Enzymes for Digestive & Industrial Use
- Spores (Bacillus subtilis, coagulants, clause, etc.) – Liquid & Powder Form
Turnkey Project Execution
- Concept to Commissioning Services
- Plasma Lab Design & Execution
- Biopharma Plant Layouts, Cleanroom & HVAC Setup
- Cold Chain Logistics and Plasma Traceability Systems