Quality Assurance, Compliance & Regulatory Affairs

We provide end-to-end support to help organizations meet quality standards and regulatory requirements. Our services include site audits, SOP development, risk assessments, and document control. We prepare clients for inspections and ensure readiness for regulatory agency audits. Compliance strategies are tailored to industry-specific guidelines like FDA, ICH, or ISO. We assess and improve systems, processes, and documentation for maximum efficiency and accuracy. With expert guidance, your operations remain compliant, audit ready, and continuously improving.

We provide the following services

Site Audits Client / Supplier Document Review and Handling Development of Standard Operating Procedures Process Development Risk and Impact Assessment Inspection Readiness Compliance Services

We conduct thorough site audits to evaluate product quality, processes, and system compliance.
Our audits identify gaps, risks, and improvement areas to ensure regulatory and operational readiness.
Whether internal or external, we help you maintain high standards and pass inspections confidently.

We perform detailed audits of clients, suppliers, and vendors to ensure compliance and performance standards.
Our evaluations cover quality systems, regulatory alignment, and risk management practices.
These audits support strong partnerships, reduce liability, and ensure consistent product and service delivery.

We provide meticulous document review and handling to ensure accuracy, compliance, and consistency.
Our team verifies content against regulatory standards and organizes documents for easy retrieval.
Ideal for audits, quality control, and operational efficiency across any regulated industry.

We create clear, compliant Standard Operating Procedures tailored to your workflows and regulatory needs.
Our SOPs promote consistency, efficiency, and accountability across your organization.
Each document is crafted to meet industry standards and support training, audits, and quality control.

We design and optimize business processes to improve efficiency, compliance, and scalability.
Our approach maps current workflows, identifies gaps, and implements streamlined, effective solutions.
Each process is tailored to align with industry standards, regulatory requirements, and organizational goals.

We conduct thorough risk and impact assessments to identify vulnerabilities and evaluate potential consequences.
Our approach helps you prioritize mitigation strategies, maintain compliance, and protect operations.
Each assessment is data-driven, aligning with industry regulations and organizational objectives.

We prepare your organization for regulatory inspections with comprehensive assessments and mock audits.
Our services ensure documentation, processes, and teams are aligned with compliance standards.
With tailored guidance, you’ll approach every inspection confidently and audit-ready.

We offer end-to-end compliance services to help your organization meet regulatory and industry standards.
Our support includes audits, policy development, training, and ongoing monitoring for sustained compliance.
We tailor solutions to frameworks like ICH, FDA, ISO, and other sector-specific regulations.