Looking for a wholesaler's license? Our expert support ensures inspection readiness, covering QMS development, staff training, and gap analysis to support your wholesale application.
Our former inspectors are ready to assist. We offer MHRA-style GDP audits to prepare you for inspection. We will thoroughly review your operation and support you for any upcoming inspections.
As former MHRA inspectors and gold standard-trained RPs, we offer contract services as Responsible Person(s) on your WDA. Gain unparalleled insights from our unique experiences as inspectors and across industry with exposure to global distribution networks.
Want to distribute medicines worldwide? Utilize our experience in managing global distribution networks and navigating international regulators. We can advise on distributing medicines to various territories, ensuring compliance across physical imports, exports, and introduced medicines.
Require help with writing SOPs and managing quality systems? We can help you develop a GDP compliant quality system, including developing bespoke SOPs, CAPAs, deviations, change controls, and transition to an eQMS with our partners.
Operating as a virtual distributor utilising third parties for physical product supply? We can aid in crafting compliant wholesale distribution models tailored to your virtual distribution business.
Considering acquiring a new business or onboarding a new supplier? We provide assistance in reviewing their compliance history and robustness, conducting thorough due diligence and risk assessment before onboarding. Ensure a reliable and robust supply chain through our support.
Engaging with third parties? Whether it's 3PL warehouses, contractors, or transport providers, we can audit your third-party partners for regulatory compliance. We'll also assist in establishing contracts and defining quality technical responsibilities.
Operating an organization with multiple legal entities across territories? Seeking assistance in developing a compliant distribution model? We can help you create compliant business models and review purchase and sales activities to ensure fiscal transactions align with GDP requirements.
We specialize in understanding your business, offering professional opinions on quality decisions aligned with Human Medicines Regulations. Our compliance solutions include written opinions to justify operational and commercial decisions and fully documented risk assessments to review key risk areas that may lead to regulatory non-compliance.
Looking to expand your knowledge and understanding of Good Distribution Practice? We can provide specialised in-house training for you and your team.
To ensure GDP-compliant medicines distribution, a reliable transport solution is essential. We can support with validating chosen transport solutions including vehicle review and route validation. Whether using third parties, your own vehicles or bespoke packaging solutions, we conduct risk assessments and implement robust monitoring processes, providing you with the oversight and confidence that your products are distributed in line with labeled requirements for both ambient and cold-chain medicines.