Regulatory Support.
Central Pharma offers regulatory services to the healthcare sector, including project management, importation and QP batch release, including release for sale, and much more. Our tailored regulatory packages are based on requirements and timescales.
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Dedicated Project Management.
Our pharmaceutical regulatory services include providing a dedicated account manager to guide you through each project from concept to delivery. Your account manager will be involved in every aspect of the project, from batch record preparation, managing logistics, to answering technical queries.
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Drop us a message to discover our full range of services tailored to your business and find out how Central Pharma can be your intelligent pharmaceutical partner.
Regulatory support.
We offer regulatory support for our customers providing guidance and potential solutions to regulatory hurdles. We are experienced in handling a wide range of therapeutic areas and project types, from small to large molecule, sterile to non-sterile. Customers are provided with a tailored regulatory package based on their requirements and timescales and are then assigned a team that will work with them accordingly.
Procurement.
Central Pharma regularly manages purchasing and inventory of packaging materials and other stock items on behalf of our customers. This service is underpinned by our expert network of manufacturers, suppliers, distributors and logistics providers, each of whom have been audited and approved by our QA team. We provide full traceability of inbound goods, from receipt through to processing or dispatch.
Transport & distribution.
Our group of approved and audited transport providers can support your transport and distribution requirements for licenced medicinal products and controlled substances. Our vendors are GMP and GDP certified, can handle shipments requiring specific temperature conditions including refrigerated 2-8°C and controlled ambient +15 to +25°C, and provide a range of express and economy solutions. For our Cell and Gene Therapy customers, we offer same-day delivery Regulatory Support that ensure time-critical items arrive on site ready to be processed to meet stringent manufacturing process timelines.
QP Batch release – including release for sale.
Our QP regulatory support ensures that your product is available on the market quickly and effectively, certifying that it has been manufactured to the highest standards.
Within the EU, all commercially licenced products manufactured or imported by organisations must have a Qualified Person (QP) to approve and release each batch. QPs will have gained personal knowledge of the quality systems used at the manufacturing site, usually through an EU Good Manufacturing Practice Audit.
At Central Pharma, our QPs are assigned projects according to their specialist expertise and have a personal and legal responsibility as defined by EU legislation.
Our experts help clients navigate the complex and evolving regulatory environment to ensure your product is imported and released correctly.
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Specialist Storage and Logistics
Our portfolio of licences and dedicated customer service personnel allow us to provide flexible warehouse solutions for all our customers.
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Filling and Packing
We regularly invest in machinery and equipment to expand our filling and packing capacity. The flexible, manual and fully-automated systems we use are designed to meet the varying budgets, products and market needs of our customers.
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Serialisation
Our Serialisation service comes with a wealth of experience and competency. With track and trace, we combat counterfeiting, keeping patients and your business safe.
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