Pharmaceutical, Medical Device, Cell & Gene and Healthcare Regulatory Support.

Regulatory consultancy, supply chain management, QP release and more, Central Pharma aims to be your intelligent Pharmaceutical, Medical Device, Cell & Gene and Healthcare partner.

Dedicated Project Management

We provide 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.

QP Batch release –  including release for sale

Our QP Regulatory Support make sure your product is available on the market as quickly and as effectively as possible certifying that your products have been manufactured to the very 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.

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.

Site of importation

Central Pharma has great depth of experience in providing expert regulatory advice and Regulatory Support. We have a history of developing strategies to effectively meet your immediate and long-term product or company regulatory requirements.

Service Overview:

  • Licence Submissions, Variations and Renewals
  • Ongoing Licence Maintenance
  • Regulatory Strategy: Advice on EU, US Legislation
  • GMP/GDP Gap Analysis & Audit
  • Stability & Shipping Studies

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.

Explore our solutions

What we do
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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What we do

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Drop us a message to discover our full range of Regulatory Support tailored to your business and find out how Central Pharma can be your intelligent Pharmaceutical, Medical Device, Cell & Gene and Healthcare partner.

 

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