Compliance in Health Science Research Laboratories
Welcome to PharmOut, where we are committed to aiding scientists in health science research laboratories throughout the Asia Pacific region in achieving the highest standards of compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). We offer end-to-end solutions, spanning from the initial lab design and engineering, the development of Standard Operating Procedures (SOPs) to auditing for regulatory compliance.
Laboratory Design and Engineering Tailored to Your Needs
Our services commence with the initial design and engineering of laboratories. We don’t believe in a one-size-fits-all approach; instead, we design your laboratories around your specific needs and the researchers who use them. Our expert team will work closely with you to ensure your facility is tailored to your operations, fostering an environment that promotes productivity and compliance.
SOP Development for Sample Preparation and Testing
The heart of every successful laboratory lies in its procedures. We assist you in developing comprehensive, easy-to-follow SOPs that cater to your lab’s specific needs for sample preparation and testing. Our SOPs are designed to be clear, concise, and effective, ensuring that your laboratory processes are standardised, reproducible, and, most importantly, compliant with the latest GCP and GLP requirements.
Ensuring Regulatory Compliance through Auditing
Navigating the regulatory landscape can be complex and overwhelming, but it doesn’t have to be with PharmOut. We conduct thorough audits of your labs to ensure you meet and maintain the stringent standards required for regulatory compliance. Our experienced auditors provide constructive feedback and practical solutions to address any areas of non-compliance, ensuring you meet the exacting standards of GCP and GLP.
This auditing service is focused on health science research laboratories and organisations preparing clinical trial materials or early-stage commercial product at the transition of first-in-human trials.
This auditing service is focused on health science research laboratories and organisations preparing non-clinical materials for testing in organisms and the environment.
Quality Management Systems and Traceability
We understand that having a robust Quality Management System (QMS) and a fully traceable process is pivotal in guaranteeing the conformity, consistency, and reliability of your lab practices. We will help you establish a strong QMS that ensures every step in your process, from sample reception to results reporting, is documented, controlled, and fully traceable. Our goal is to help you maintain an unbroken chain of accountability that demonstrates your commitment to quality and regulatory compliance.
At PharmOut, we are dedicated to making GCP and GLP compliance in health science research laboratories as seamless as possible. Our unique blend of technical expertise and practical experience ensures that we offer solutions that are not only compliant but also scientifically robust and operationally efficient. Let us assist you in creating a laboratory environment that fosters excellence, promotes compliance, and delivers reliable and reproducible results. Your journey to compliance starts here.
If you are resource-poor and need more skilled professionals working in your research laboratory, with our extensive network, PharmOut can help you find the right person to provide the much-needed experience either on a contractual, temporary or permanent basis.
PharmOut can design health science research laboratories or clean rooms that meet both your workflow and regulatory requirements. We believe in designing-in quality from the very beginning as well as building-in quality throughout a process.
We offer project management services for research that can help you get from the initial idea all the way to the final result, all the while complying with the required regulations.
Get in Touch
If you would like to learn more about our services, request a quote or ask any questions please fill out our enquiry form here.