Our Services

Whether you're building your first GMP-compliant facility or expanding globally, Skalli Group is your partner at every stage.

Regulatory Compliance

We guide you through complex FDA and global regulatory frameworks. From GRAS to NDI and label reviews, we cover it all.
Our experts help classify products, draft SOPs, and mitigate risk. Stay reduce delays, and move confidently to market.

Quality Systems & GMP

Build a strong QA/QC infrastructure aligned with 21 CFR Part 111. We create systems for traceability, deviations, CAPAs, and audits. Our custom manufacturing and batch record templates streamline operations.

Technical Writing

We specialize in precise, submission-ready regulatory documents. From SOPs and validation protocols to white papers and rationales, our writers turn science into strategy and compliance into clarity. Trust us to communicate your quality.

Audit & Inspection Readiness

Prepare with confidence for FDA, NSF, UL, or ISO inspections. We perform mock audits, identify gaps, and train your team. Our experts respond to 483s and Warning Letters effectively. Be ready, responsive, and ahead of regulatory scrutiny.

Regulatory Strategy

Gain a proactive plan tailored to your product and market goals.
We craft market entry strategies, risk maps, and compliance roadmaps. Our approach integrates innovation with regulatory foresight.

Global Compliance

Expand internationally with confidence and local insight. We support compliance with EFSA, NHP. From import/export rules to partner vetting, we streamline access. Navigate regulatory landscapes across Europe, Asia, LATAM, and beyond.