For registered medical practitioners & hospital procurement teams Patna, Bihar  โ€ข  mediskyltd@gmail.com
QUALITY & COMPLIANCE

Uncompromised Quality Standards & Clinical Safety

Every formulation and surgical consumable marketed by Medisky Lifesciences strictly adheres to international pharmacopoeial standards, WHO-GMP certified manufacturing, and ESPEN clinical guidelines.

Medisky Quality Assurance
Quality Assurance & Certification Standards

Our Four Pillars of Quality Assurance

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WHO-GMP & ISO 9001

Partnered strictly with state-of-the-art WHO-GMP and ISO 9001:2008 certified manufacturing facilities with mandatory batch COA testing.

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ESPEN 2022 Aligned

Our clinical nutrition and trace-element products follow European Society for Clinical Nutrition and Metabolism dosing protocols.

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100% Sugar-Free Safety

Parenteral amino acid infusions (Aminosky-10%) strictly avoid Sorbitol and Xylitol to eliminate IV toxicities and acute renal risks.

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AQL 1.5 Surgical Standards

Touch-Med nitrile examination gloves are quality-inspected to AQL 1.5 pinhole rating, exceeding ASTM D 6319, EN 455, and CE standards.

Regulatory Approvals & Testing Specifications

Product Category Governing Standard Key Safety Certification Primary Clinical Benefit
Parenteral Nutrition
(Aminosky-10% & Glutasky)
ESPEN Guidelines / IP Specifications 100% Sorbitol & Xylitol Free Eliminates IV sugar-alcohol renal toxicity and protects hepatic function in ICU patients.
3rd Gen Iron Therapy
(Ferric-CM)
Parenteral Iron Safety Protocols Ferric Carboxymaltose 500mg (Dextran-Free) Rapid Hb elevation (+4.4 g/dL), eliminates dextran anaphylaxis risk, safe for non-dialysis CKD & pregnancy.
3rd Gen Colloid Expander
(Tetravan 130/0.4)
Plasma Volume Expander Guidelines HES 6% 130/0.4 Molar Substitution Safest 3rd gen colloid infusion for up to 1L blood loss replacement without tissue accumulation.
Trace Element Therapy
(ZincFlow IP)
ESPEN 2022 ICU Trace Element Protocol Zinc Chloride IP Injection 1 mg/ml Essential Day 1 ICU supplementation for wound healing, major burns, GI fistulas, and sepsis reduction.
Surgical Consumables
(Touch-Med Nitrile Gloves)
ASTM D 6319 / EN 455 / EN 374-5 VIRUS AQL 1.5 Rating, US FDA & CE Approved 100% Powder-Free & Latex-Free, inner polymer coated for easy donning without protein allergy risks.

Batch Certificate of Analysis (COA) & Regulatory Dossiers

Our quality assurance team provides batch-specific Certificate of Analysis (COA) documentation, WHO-GMP site master file certificates, and technical product literature for hospital purchase committees and pharmacy procurement teams.

Have a quality compliance or hospital documentation request?

Our quality assurance department can provide Certificates of Analysis (COA) and regulatory dossiers instantly.

Contact QA Team
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