Qualified Person (QP) Services
Qualified Persons (QPs) are essential to ensuring that medicinal products meet the highest standards of quality, safety, and compliance. Our QPs provide certification and oversight for both human and veterinary medicines, covering a wide variety of dosage forms including tablets, capsules, liquids, creams, steriles, and metered-dose inhalers. Their expertise guarantees that products are manufactured, stored, and released in accordance with strict regulatory requirements.
Our QPs manage the batch release process in full compliance with Good Manufacturing Practice (GMP). They verify that all production processes and quality control measures meet regulatory expectations before products are released to the market. This oversight protects patient safety, reduces the risk of non-compliance, and ensures consistent product quality across every batch.
In addition to batch release, QPs audit and monitor the entire supply chain. This includes API manufacturers, raw material suppliers, packaging facilities, and contract laboratories. By ensuring all suppliers meet strict quality standards, our QPs maintain the integrity of the product from initial manufacture through final distribution.
We offer flexible QP services to meet the needs of our clients, whether they require full-time coverage, part-time support, or assistance during peak demand periods. This scalability allows companies to maintain continuous compliance without investing in permanent in-house personnel, providing both operational efficiency and regulatory assurance.
Beyond operational oversight, our QPs provide strategic guidance on regulatory compliance, quality management systems, and process optimization. Their input helps clients identify potential risks, streamline operations, and maintain a strong regulatory position, ensuring that both products and processes consistently meet national and international standards.
Ready to bring your products to market with confidence? Get in touch today.
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