Stringent Quality Protocols & Schedule M Compliance

Quality Assurance, Testing Standards & Regulatory Compliance

At Riomedica Healthcare Pvt. Ltd., therapeutic efficacy and patient safety form the cornerstone of every formulation. Our portfolio of 700+ medicines complies with rigorous WHO-GMP, ISO 9001:2015, and CDSCO standards, backed by batch-by-batch Certificate of Analysis (COA) testing.

WHO-GMP & ISO 9001:2015 Certified
100% DCGI Approved Formulations
GLP Certified Analytical Laboratories
Stringent HPLC & Dissolution Profiling
Cold-Form ALU-ALU Packaging Protection
Batch-Wise Certificate of Analysis (COA)
Certified Manufacturing Facilities:
Akums Drugs Windlas Biotech Biodeal Pharma Medicef Pharma Mascot Health Series

Request Batch COA / Test Report

Doctors, pharmacists, and institutional buyers can request official Certificate of Analysis verification.

100%
DCGI Approved Formulations
WHO-GMP
Certified Manufacturing Facilities
Zero
Compromise Quality Philosophy
28+
States Dispensing With Trust
Total Quality Management

Our 5-Stage Pharmaceutical Quality Assurance Architecture

Comprehensive testing at every step from raw molecule testing to final patient packaging guarantees unwavering therapeutic efficacy.

01

API & Excipient Testing

Every active pharmaceutical ingredient (API) and functional excipient undergoes rigorous identity and purity validation before entering formulation batches.

  • Raw Material Assay & Purity Testing
  • Heavy Metals & Arsenic Screening
  • Particle Size & Bulk Density Controls
02

In-Process Quality Checks (IPQC)

Continuous monitoring during granulation, compression, and coating prevents batch variations and guarantees uniform dosage delivery.

  • Tablet Hardness, Thickness & Friability
  • Weight Variation (±1% strict limits)
  • Disintegration Time Profiling
03

Finished Formulation Assay

Advanced analytical chromatography verifies that each tablet, capsule, or vial contains exactly 100% of the declared therapeutic dose.

  • High-Performance Liquid Chromatography (HPLC)
  • In-Vitro Dissolution Rate Testing
  • Related Substances & Impurity Limits
04

Microbiological Bioburden Screen

Zero tolerance for microbial contamination across injectables, oral liquids, eye drops, and dry powder formulations.

  • Total Microbial Count (TAMC & TYMC)
  • Sterility & Bacterial Endotoxin (LAL) Testing
  • Cleanroom Particle Count Validation
05

Barrier Packaging & Stability

Superior packaging engineering safeguards the molecular stability of sensitive medicines throughout Indian tropical conditions.

  • ALU-ALU Cold-Form Aluminium Blisters
  • Accelerated Stability Testing (40°C / 75% RH)
  • Tamper-Evident Security Seals
06

Batch COA & Release Protocol

No consignment leaves the warehouse without a formal Certificate of Analysis authorized by our Qualified Quality Assurance Managers.

  • Signed Analytical Batch Release
  • Pharmacopoeial (IP/BP/USP) Standard Match
  • Complete Archive Sample Preservation
Accreditations & Licensing

Adhering to Indian & Global Regulatory Benchmarks

Our operational and clinical procedures comply with the statutory guidelines mandated by drug regulatory authorities.

WHO-GMP Certified

World Health Organization Good Manufacturing Practices ensuring state-of-the-art facilities and cleanliness.

ISO 9001:2015

Internationally audited Quality Management System governing every business and logistical interaction.

DCGI Approved

All 700+ formulations are formally sanctioned by the Central Drugs Standard Control Organisation (CDSCO).

GLP Laboratory Audits

Good Laboratory Practices adhering to calibrated analytical instruments and standardized test protocols.

Need Quality Validation for Your Hospital or Distribution Network?

Our regulatory affairs team provides full compliance dossiers upon request.

Frequently Asked Questions

Answers Regarding Pharmaceutical Quality & Compliance

Transparency in raw materials, stability testing, and regulatory documentation.

How does Riomedica guarantee batch-to-batch consistency?
Batch consistency is maintained through validated Master Formula Records (MFR) executed in automated facilities. Every single batch is produced under identical temperature, humidity, and blending durations, followed by comparative HPLC testing against certified reference standards.
Where are medicines manufactured and tested?
Our formulations are manufactured and tested at India's foremost WHO-GMP compliant plants: Akums Drugs, Windlas Biotech, Biodeal Pharma, Medicef, Mascot, and Ultra Drugs. Each plant operates in-house GLP-compliant analytical testing laboratories with independent Quality Assurance oversight.
How can I obtain a batch Certificate of Analysis (COA)?
Franchise associates and institutional purchasers receive COAs with their delivery documents. If you need a duplicate COA, simply submit our online form with the Product Name and Batch Number, or email sales@riomedicahealthcare.com with your invoice number.
What shelf life and storage conditions apply to Riomedica products?
Formulations typically carry a 24 to 36-month shelf life backed by real-time and accelerated stability studies. Packaging clearly designates storage criteria: 'Store below 25°C in a dry place, protect from direct light.' Cold-chain items (e.g., specific injectables) are shipped with monitored thermocol and ice packs.
Are all product ingredients approved by the DCGI?
Yes. Every formulation is strictly approved by the Drugs Controller General of India (DCGI) and respective state drug authorities. We strictly avoid unapproved fixed-dose combinations (FDCs).