Regulatory Support.

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

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.