The Clinical Trial Package
We offer all the services for a successful clinical trial as package or at a glance
Before the clinical trial, we will:
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Plan the quantities to produce, based on batch sizes, clinical needs, development needs, shelf life and other relevant constraints.
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Localize relevant CROs, central labs, IRT, equipment and other vendors.
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Negotiate with the vendors until agreement is reached.
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Find the relevant distribution centers around the globe, audit them and recommend the right one.
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Define the IRT according to clinical needs.
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Find distribution channels for the medicines, equipment, patient samples and other needs
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Write the necessary SOPs to support the regulatory submissions.
During the clinical trial, we will:
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Track daily the inventory and shipment status.
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Perform tele conferences with the parties involved in the clinical trial.
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Constantly check the cost and pricing of the services acquired from the different vendors.
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Take care of any deviation happened in the supply chain.
After the clinical trial, we will:
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Coordinate the return of the IMP, equipment and ancillaries to the central depot for destruction or return to the sponsor.
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Close all the agreements with the vendors.
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Prepare the necessary reports for the regulatory authorities.
Logistics
With a wide experience in all kinds of shipments, we at PharMakeable will arrange for you, the right service for your product.
Our service includes:
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Find the best forwarders.
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Perform a tender between the relevant companies, without compromising the quality of the products transported.
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Coordinate with all parties involved in the shipment.
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Assist with the import/export permit in every country.
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Manage all the deviation happened during the shipment.
Purchasing
At PharMakeable we offer our vast experience in all kind of procurement, from local small contracts to multi million dollar agreements of chemicals, reagents, electronic parts, machinery, lab equipment, CROs, CMOs, central depots, 3PL, central labs and any other service required.
Services included:
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Write the User Requirement Specification for any equipment or software required.
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Build RFP/RFQ for any service or equipment.
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Localize the most relevant suppliers.
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Negotiation management and agreement approval.
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Track the supply of the products and services.
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Build a KPI with the relevant elements to manage.
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Perform qualification of the required vendors.
Planning
At Pharmakeable we believe that accurate planning is the key to operational excellence and business success.
For this reason, we offer our clients our experience and custom-made planning tools.
Our service includes:
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Inventory planning
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Production planning
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Supply planning
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Build the BOM and analyze the purchasing recommendations
Risk Management
Understanding the risks that the business is exposed is the key to the business continuity plan.
At PharMakeable, we will analyze the entire supply chain of the company, describe the weakest points, threats and risks and will perform the necessary actions to neutralize these factors.
GDP Compliance Preparation
GDP Compliance Preparation
Quality Assurance
A high-quality standard is the key of business success. For this reason our vast experience and continuously learning the newest quality standard guidelines, make us the right option for your need.
Our QA services include:
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Implementation of ISO 9001
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Implementation of GDP (Good Distribution Practice)
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Internal & external audits
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Gap analysis
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CAPA Management
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Employees Training
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Complaints management