Quality and Compliance (QC)
CERTIFICATIONS:
Certification is more than a badge—it’s a powerful statement of your organization’s commitment to quality and compliance. At Altiveno, we provide end-to-end support for achieving certifications such as ISO, GMP, and other internationally recognized standards. Our consultants work closely with your teams to prepare documentation, align processes, and implement the necessary controls that ensure a smooth certification journey.
We don’t just help you pass an audit; we help you build a foundation that sustains compliance long after the certificate is awarded. With Altiveno’s guidance, certification becomes not just a milestone but a springboard for market expansion, enhanced credibility, and stronger stakeholder trust.
QUALITY MANAGEMENT SYSTEM (QMS) DEVELOPMENT:
A well-designed Quality Management System is the backbone of any compliant organization. Altiveno specializes in developing QMS frameworks that are tailored to your operations, scalable to your growth, and aligned with global regulatory expectations.
Our approach goes beyond templates—we take the time to understand your processes, culture, and goals, then design a system that integrates seamlessly into your daily operations. From defining policies and procedures to training staff and embedding continuous improvement cycles, we ensure your QMS is not only compliant but also a driver of efficiency and excellence. With Altiveno, your QMS becomes a living system that evolves with your business, rather than a static set of documents.
GAP ANALYSES & MOCK INSPECTIONS:
Regulatory inspections can be daunting, but preparation transforms them into opportunities. Altiveno’s gap analyses provide a clear, detailed picture of where your current practices align with requirements—and where they fall short. We identify risks, inefficiencies, and vulnerabilities, then provide practical recommendations to close those gaps.
Our mock inspections replicate the rigor of real regulatory audits, giving your teams the chance to experience the process in a controlled environment. This proactive approach builds confidence, sharpens readiness, and ensures that when the real inspectors arrive, your organization is prepared to demonstrate compliance with clarity and assurance.
AUDITING SERVICES:
Independent audits are a cornerstone of compliance and continuous improvement. Altiveno offers comprehensive auditing services that cover internal systems, supplier networks, and regulatory requirements. Our auditors bring a fresh, objective perspective, uncovering issues that may be overlooked internally and providing actionable insights to strengthen your compliance posture.
We don’t stop at identifying problems—we partner with you to implement corrective and preventive actions that deliver lasting improvements. With Altiveno’s auditing expertise, you can be confident that your systems are not only compliant today but resilient enough to withstand tomorrow’s challenges.
QUALIFIED PERSON (QP) SERVICES:
In the pharmaceutical sector, the role of the Qualified Person is critical to safeguarding patient safety and ensuring regulatory compliance. Altiveno provides access to highly experienced QPs who bring both technical expertise and regulatory authority to your operations.
Our QPs oversee product release, verify compliance with GMP, and ensure that every batch meets the highest standards before reaching the market. By partnering with Altiveno, you gain more than a regulatory requirement—you gain a trusted guardian of product integrity, patient safety, and organizational reputation.
QUALITY RISK MANAGEMENT (QRM):
Every organization faces risks, but how those risks are managed defines long-term success. Altiveno applies structured Quality Risk Management methodologies to help you identify, assess, and control risks that could impact product quality or compliance.
We work with your teams to prioritize risks, allocate resources effectively, and implement controls that reduce vulnerabilities. Our QRM approach is not about avoiding risk altogether—it’s about making informed, strategic decisions that protect your operations and strengthen resilience. With Altiveno, risk management becomes a proactive tool for growth, not just a defensive measure.
