Regulatory Support

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. View our latest information sheet.

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Dedicated Project Management.

Our 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.

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
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Looking for a tailored solution?

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.

Contact us

Regulatory Support

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 goods, from receipt through to processing or dispatch.

Transport & distribution.

Our group of approved and audited transport providers can support all of your transport and distribution requirements. Our vendors are GMP and GDP certified and can handle shipments requiring specific temperature conditions, including ambient, 2-8, -20, -80 degrees and liquid nitrogen. We offer same-day delivery that ensures time-critical items arrive on site ready to be processed to meet stringent manufacturing process timelines.

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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.

Our experts help clients navigate the complex and evolving regulatory environment to ensure your product is imported and released correctly.

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Looking for a tailored solution?

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.

Contact us