How Shiva Analyticals Helps You Stay Compliant, Confident, and Regulator‑Ready.
As global regulators sharpen their focus on nitrosamines, pharmaceutical manufacturers face a new reality: risk assessment and control are no longer reactive exercises—they are integral to Good Manufacturing Practice (GMP) excellence. In this evolving regulatory era, compliance is measured not only by documentation, but by scientific rigor, analytical precision, and proactive quality systems.
Shiva Analyticals (India) Private Limited partners with manufacturers at every stage of this journey—turning regulatory complexity into a structured, auditable, and sustainable compliance strategy.
End-to-End Nitrosamine Risk Management
We support you from identification to mitigation. Our experts conduct holistic nitrosamine risk assessments across APIs, excipients, manufacturing processes, and packaging systems. By mapping all potential formation pathways—synthetic, degradative, and migratory—we help you meet FDA, EMA, ICH M7(R2), and CDSCO expectations with clarity and confidence.
GMP Embedded by Design
At Shiva, GMP is not a checklist; it is the foundation of our operations. We seamlessly integrate nitrosamine controls into:
- SOPs and batch records
- Supplier qualification and material change control
- CAPA systems and lifecycle management
This ensures traceability, inspection readiness, and consistent product quality across global markets.
Advanced Analytics for Ultra‑Low Detection
Regulatory compliance today demands data you can defend. Our state-of-the-art LC‑MS/MS and GC‑MS platforms enable detection of nitrosamines at ultra‑trace levels—well below current Acceptable Intake limits. Fully validated per ICH Q2(R1), our methods deliver reliable, reproducible, and regulator-ready results, even in complex formulations and multi‑analyte scenarios.
Science‑Led, Regulation‑Aligned Solutions
Our multidisciplinary teams—spanning analytical science, quality assurance, and regulatory affairs—work collaboratively to deliver:
- Compound‑specific and product‑specific control strategies
- Process optimization and mitigation validation
- Rapid response to regulatory updates and inspections
Your Trusted Compliance Partner
In an era where nitrosamine risk defines product trust, Shiva Analyticals stands as a partner committed to protecting patient safety and safeguarding your portfolio. We help you move beyond compliance—toward confidence, credibility, and long‑term regulatory success.
Because GMP isn’t just about meeting standards—it’s about setting them.
Partner with Shiva Analyticals and future‑proof your products in the nitrosamine era.
About Shiva Analyticals
Shiva Analyticals is a leading testing laboratory in India, offering precise analytical services across industries such as pharmaceuticals, food, agriculture, and petroleum. Specializing in regulatory compliance and safety, Shiva uses state-of-the-art facilities and cGMP-compliant practices to deliver reliable, tailored solutions that help businesses ensure product quality and meet industry standards.