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Bulk Drug Characterization
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Pre-formulation Studies/Formulation Development
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EMINENT personnel will provide expert services in the areas of formulation development, study product manufacturing, process validation, stability protocol preparation, implementation, and monitoring services. Manufacturing and analytical testing services are provided through our pharmaceutical research laboratory as well as from our approved subcontractors. EMINENT will review all Chemistry, Manufacturing and Controls (CMC) regulatory documents related to product development and will prepare suitable reports in compliance with cGMP regulations for incorporation into respective regulatory documents.
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Clinical Supplies Manufacturing
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EMINENT has capabilities to manufacture matching placebo formulations for solid oral dosage forms (tablets and capsules) and has good working relations with the contract manufactures to develop, manufacture and release a variety of pharmaceutical formulations including soft gel capsules. We are routinely involved in developing the formulations for oral, parenteral, and nasal routes of drug delivery. EMINENT has subcontract arrangements with contract manufacturing companies to manufacture study products. If the need arises EMINENT can accomplish all manufacturing activity through subcontract services and perform required research, development work, and analytical testing work in our Pharmaceutical Research Laboratory.
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Design and Development of Container/Closure System
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Finished Product Release Testing
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Stability Indicating Methods Development/Validation
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Implementation of Stability Studies
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Regulatory Consulting Services
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EMINENT personnel are experienced in the provision of quality clinical trial material management services for phase I to IV studies and have valuable knowledge of Good Manufacturing Practice (cGMP) Regulations as they apply to clinical study product development. EMINENT personnel are also well familiar with Investigational New Drug Application (IND), New Drug Application (NDA), and Drug Master Files (DMF) filing with the US Food and Drug Administration. Contract consulting services may be particularly useful to small, research based pharmaceutical and biotechnology companies that are entering into the clinical drug development for the first time, and to Contract Research Organizations (CRO) and Data Coordinating Centers (DCC) involved with clinical studies for clinical product development, patient specific packaging and labeling, distribution to clinical sites, and clinical site inventory monitoring.
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Inventory Management and Storage (USP/Custom Conditions)
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EMINENTs Investigational Drug Repository drug product and stability product storage (controlled room temperature, refrigerated, freezer, and ultra-low freezer areas) are controlled and monitored 24/7 by a state-of-the-art Data Acquisition System. The general warehouse area is equipped with redundant HVAC system (Eleven 20 ton units) to maintain warehouse storage temperatures between 20-25°C throughout the year to preserve the integrity of the drug products. EMINENT has the in-house developed validated software to manage the inventory for all study products and supplies.
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Primary Study Product Packaging
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EMINENT staff are available to assist and advise the study sponsors on container design and development of the clinical study product with special emphasis on preserving the integrity of the study product, stability and process validation. EMINENT will provide clean rooms with automated filling machines for primary packaging needs of solid oral dosage forms. The rooms will be temperature controlled and will be monitored for relative humidity. Strict adherence to incoming materials inspection and release, in-process sample testing, finished product testing, thorough equipment and packaging rooms cleaning, and cleaning verification procedures ensure that the quality and integrity of the packaged product is not compromised at any stage of the study product packaging.
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Secondary and Patient-Specific Kit Packaging
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EMINENT premises will include a large, temperature controlled packaging area which can be configured to suite any secondary packaging procedure. Employees are fully trained on cGMPs and pertinent internal EMINENT Standard Operating Procedures to ensure that tasks performed are of the highest quality. EMINENT can procure suitable packaging materials or utilize sponsor provided materials as required. In addition, EMINENT is able to provide expert opinion on study package design in order to facilitate study protocol and patient compliance. EMINENT staff possesses high level of expertise in the patient specific study medication kit assembly.
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Clinical Subject Randomization
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EMINENT can provide clinical subject randomization services using validated statistical randomization techniques and in-house developed validated software (Investigational Drug Management System, IDMS) for a variety of experimental designs including twin crossover designs. The resultant randomization data will be provided in custom formats as well as in electronic media that suites clients requirements.
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Label Design and Production
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EMINENT is able to design and produce a comprehensive array of randomized, blinded, and open clinical trial labels in full compliance with federal regulations. One, two, and three-part labels and custom designed blinded labels which may include bar codes, graphics (sponsor logos) or foreign language text, are all produced under strict controls, consistent with the requirements of cGMPs. Randomization codes can be generated internally or provided by sponsors for incorporation into label generation databases. Laser, thermal transfer, and impact printers are utilized to generate labels which will precisely meet the clinical study requirements. EMINENT will test the label stock materials with respect to the storage temperature of the study product. Quick turn-around of label generation and QA/QC checks by EMINENT will result in timely availability of labels to meet packaging deadlines.
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Shipping Container Validation
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EMINENT has the capabilities of validating the Shipping Container for various types of packages. Also we perform the country specific validation for the containers.
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Storage of Controlled Substances
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EMINENT has the capabilities of storage, packaging and distribution of Schedule II, III, IV, and V controlled substances for clinical use as per DEA regulations.
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Clinical Site Inventory Monitoring
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EMINENT has the abilitiy to monitor the inventory at site level for any clinical study. We have validated software to perform study product allocation and monitor the inventory. Once the inventory goes below the threshold the system will automatically generates the shipment and sends a reminder to the IDR department.
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Worldwide Clinical Distribution
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Currently EMINENT is shipping the study products in more than 50 countries world wide. The temperature controlled products are shipped in validated containers to maintain appropriate temprature.
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Clinical Hot-line for Un-blinding/Drug Distribution
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EMINENT offers Emergency Investigational Drug Response Service using Nationwide Toll-free (888) Telephone lines and Nationwide Toll-free Telephone Service to answer all emergencies related to the clinical trials including study unblinding, emergency shipments, and Adverse Event Reporting during non-business hours, weekends and holidays. All calls will be answered by qualified technician and/or staff pharmacist. These services will also handle all emergency clinical drug shipment requests.
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Return Drug Processing
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EMINENT provides the Agent Return Form and necessary instructions for all clinical sites to return the unused, used, and expired drug products supplied by EMINENT for a specific protocol. The proposed Investigational Drug Inventory Management system has the capability to process the return drug products with patient specific accountability.
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Study Product Reconciliation and Destruction
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EMINENT has procedures in place to perform different types of drug recalls requested by the drug manufacturers as well as regulatory agencies such as the FDA. At the time of the recall EMINENT will notify (via a drug recall letter) all study investigators, coordinators, and the clinical pharmacists involved about the recall with explicit details of the study products involved. Further, EMINENT will follow-up with each non-complying clinical site by telephone calls when a notification for replacement is not received from the site. Once all the information is compiled for replacement Batch Records are generated for performing the packaging and labeling activities to replace the expired and recalled medication for the required sites.
Once the return drug products are received at EMINENT, the technicians involved will process all the returns and complete the accountability records. All the processed drug returns are packaged into special medical waste boxes provided by EMINENT subcontractor for safe disposal through incineration. These boxes containing returned drug products are stored in a segregated area away from the active inventory. At the end of the month EMINENT staff will prepare a manifest for the disposal of the drugs and the waste management company will pick-up the products for disposal. Upon disposal of the special medical waste as per applicable local, state, and Federal regulations, the waste management company will provide EMINENT with a disposal certification.
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cGMP Auditing
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Implementation of Compassionate Use Patient Assistance Programs
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Biological Specimen Storage
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Custom Barcode Label Design and Printing
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Preparation of Biological Specimen Collection Kits
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