WHO-GMP & PIC/S Certified
Serving 50+ Countries
Delios Lifesciences
Delios
Lifesciences

Certifications & Compliance

Committed to global pharmaceutical quality standards through comprehensive certifications and regulatory compliance across all operations

Primary Certifications

Delios Lifesciences partners exclusively with certified manufacturers meeting the highest international pharmaceutical quality standards

WHO

WHO-GMP Certified

World Health Organization Good Manufacturing Practices certification ensuring global quality standards and regulatory compliance.

  • International quality assurance
  • WHO prequalification eligible
  • Global market acceptance
  • Comprehensive documentation
PIC/S

PIC/S Approved

Pharmaceutical Inspection Co-operation Scheme approval demonstrating adherence to international inspection standards and mutual recognition agreements.

  • International inspection standards
  • Mutual recognition agreements
  • EU/EEA market access
  • Stringent quality systems
ISO

ISO 9001:2015 Certified

International Organization for Standardization quality management systems certification ensuring consistent product quality, customer satisfaction, and continuous improvement.

  • Quality management systems
  • Process optimization
  • Customer satisfaction focus
  • Continuous improvement

Regulatory Compliance

Comprehensive adherence to international pharmaceutical regulations and export compliance requirements

FDA Compliance

US FDA ANDA/NDA submission standards and 21 CFR compliance

EMA Standards

European Medicines Agency MAA submission and EU GMP compliance

MHRA Compliance

UK Medicines and Healthcare products Regulatory Agency standards

ICH Guidelines

International Council for Harmonisation Q7, Q8, Q9, Q10 compliance

GDP Compliance

Good Distribution Practice for pharmaceutical supply chain integrity

GMP Standards

Good Manufacturing Practice across all production facilities

GLP Adherence

Good Laboratory Practice for analytical and stability testing

Pharmacopeial Standards

USP, BP, EP, IP compliance for all formulations

Certification Documents Provided

Complete regulatory and quality documentation for every shipment ensuring global compliance

Certificate of Analysis

Batch-wise CoA with all quality parameters

COPP / GMP Certificate

Certificate of Pharmaceutical Product as per WHO format

Free Sale Certificate

Authorization for product sale in destination country

Material Safety Data Sheet

MSDS for safe handling and transportation

Product Specifications

Detailed formulation and quality specifications

Stability Study Reports

ICH-compliant stability data for shelf-life

Analytical Test Reports

Complete analytical method validation documentation

Temperature Logs

Cold chain monitoring for sensitive products

WHO-GMP

Certified

PIC/S

Approved

ISO 9001:2015

Certified

GDP

Compliant

FDA

Ready