Supporting Services for Compliance
Regulatory Dossier Support
We assist with CoA preparation, method validation reports, and submission documentation tailored for US, EU, and South American regulatory submissions.
Audits & Inspections
Our facilities and processes are prepped for client and regulator audits—complete with CAPA procedures and proactive corrective systems.
Risk Management
Proactive strategies to minimize operational, regulatory, and patient safety risks through expert compliance frameworks.
Quality. Compliance. Trust.
At AmbiKare, quality isn’t just a promise—it’s our process. Our GMP-certified manufacturing platform delivers oral solid dosage (OSD) forms—tablets and pellets—designed to meet stringent global standards.
From SOP-driven operations to audit-ready batch documentation, we build compliance into everything we do.
Our Quality Services
What We Do to Ensure Quality & Compliance. Our robust quality framework supports the entire lifecycle—from formulation to final batch release. Key capabilities include:
Quality & Process Validation
We develop and validate manufacturing processes with defined CQAs/CPPs, executed method validations, and stability programs that stand up to stringent regulatory reviews.
Audit-Ready Documentation & Traceability
Each batch is backed by complete documentation—coA, OOS investigations, CAPA, and batch records—ensuring data integrity and full audit readiness.
Quality in Action
Explore how our quality framework delivers consistency—whether it’s pilot validation batches or commercial-scale supply. Visual walkthroughs, process snapshots, and factory audits illustrate our commitment to compliance.
