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💊 Pharmaceutical Consulting & Compliance Services

Quality • Compliance • Global Confidence

Overview

At SGQ INNOVATIONS, we help pharmaceutical organizations achieve world-class quality, regulatory compliance, and operational excellence.

Our expertise covers the full spectrum of the pharma value chain — from API and formulation manufacturing to contract research, packaging, and logistics.

We enable clients to meet stringent international standards such as WHO-GMP, EU-GMP, USFDA, PIC/S, ICH Q10, and ISO, while integrating sustainability (ESG) and digital transformation for the next generation of compliance.

“Quality by Design, Compliance by Culture.”

Our Core Services

🧪 1️⃣ GMP Compliance & Certification Support

Build and maintain strong quality systems that meet global pharmaceutical requirements.

Our Expertise Covers:

  • WHO-GMP / EU-GMP / USFDA / PIC/S Readiness

  • ICH Q7 & Q10 Quality Systems Implementation

  • Facility Design Review & Qualification (DQ, IQ, OQ, PQ)

  • Validation Master Plan (VMP) Development

  • Process & Cleaning Validation Support

  • Audit Readiness & Inspection Management

  • Data Integrity & Documentation Compliance

📋 2️⃣ Quality Management Systems (QMS) Implementation

We design integrated QMS frameworks that enhance control, consistency, and traceability.

Solutions Include:

  • ISO 9001:2015 & ISO 13485 for Pharma & Medical Devices

  • Document & Change Control Systems

  • Deviation, CAPA & OOS/OOT Handling

  • Supplier Qualification & Vendor Management

  • Product Recall & Risk Management

  • Batch Record Review & Lifecycle Documentation

🧫 3️⃣ Laboratory & Analytical Quality Assurance

Ensure your labs operate with integrity, reliability, and regulatory precision.

Services Include:

  • GLP (Good Laboratory Practice) System Setup

  • Analytical Method Validation & Transfer

  • Stability Study Protocols & Data Management

  • Calibration & Equipment Qualification

  • LIMS Implementation Support

  • Microbiology Lab Setup & Environmental Monitoring

🧩 4️⃣ ESG, EHS & Energy Integration for Pharma

Modern pharma excellence goes beyond compliance — it includes responsible operations.
We integrate Environmental, Social & Governance (ESG) practices into your compliance framework.

Our Pharma-Specific ESG Offerings:

  • ESG & BRSR Core Reporting for Pharma Manufacturing

  • PSCI (Pharmaceutical Supply Chain Initiative) Alignment

  • EcoVadis & Supplier Sustainability Score Improvement

  • Carbon Accounting (Scope 1–3) & Energy Audits (ISO 50001)

  • Waste Management, Emission Control & Zero Discharge Planning

  • Occupational Health & Safety (ISO 45001 Integration)

⚙️ 5️⃣ Equipment Qualification & Validation Support

Ensure that every piece of equipment meets design and performance expectations.

Support Includes:

  • User Requirement Specifications (URS)

  • Design & Installation Qualification (DQ, IQ)

  • Operational & Performance Qualification (OQ, PQ)

  • Calibration Program Management

  • Validation Protocols & Summary Reports

📦 6️⃣ Packaging & Supply Chain Compliance

Comprehensive solutions for secondary & tertiary packaging, traceability, and supplier assurance.

Services Include:

  • BRCGS Packaging Material Implementation

  • Serialization & Track-and-Trace Systems (GS1 Compliance)

  • GMP in Packaging & Labeling Operations

  • Supplier Audits & PSCI Supplier Readiness

  • Cold Chain & Distribution Validation

🧠 7️⃣ Training & Competency Development

Empowering pharma teams with technical, regulatory, and leadership capabilities.

Programs Include:

  • GMP Awareness & Documentation Practices

  • Data Integrity & ALCOA+ Principles

  • Quality Risk Management (ICH Q9)

  • Internal Auditor Training (ISO 9001 / WHO-GMP)

  • Laboratory & Validation Training

  • ESG & Sustainable Pharma Workshops

All trainings are interactive, audit-focused, and certificate-based, delivered by experienced GMP consultants and auditors.

🧾 8️⃣ Audit, Inspection & Regulatory Support

Prepare for and excel in audits from national and international agencies.

Our Support Covers:

  • WHO / EU / USFDA Pre-Inspection Gap Assessment

  • CAPA Planning & Effectiveness Review

  • Internal & Supplier Audit Execution

  • Remote & Onsite Inspection Support

  • Post-Audit Follow-up & Continuous Improvement

Why Choose SGQ INNOVATIONS

✅ End-to-End Expertise – From GMP to ESG, QMS, Energy & EHS integration
✅ Proven Track Record – Trusted by leading Indian and global pharma companies
✅ Certified Experts – IRCA, NABL, and ICHQ10 professionals with decades of experience
✅ Global Framework Alignment – WHO, EU, PIC/S, PSCI, and EcoVadis compliance
✅ Digital Tools – Dashboards, trackers, and automated CAPA management
✅ Sustainability Focus – Linking compliance with social and environmental responsibility

Industries We Serve

💊 APIs & Bulk Drugs
💉 Formulation & Injectables
🧴 Pharma Packaging & Devices
🧫 R&D & Analytical Laboratories
🌿 Nutraceuticals & Herbal Products

Our Promise

“Compliance with Integrity. Quality with Purpose.”

We ensure your pharmaceutical operations not only meet regulatory standards but also reflect global excellence and sustainable growth.