Pharmaceutical Industry Regulations, Clinical Trial, Drug Warehousing

Mene Research

Founded in 2003, Mene Research is based in the Gebze Organized Industrial Zone in Turkey. The company was formed to harness the expanding potential of drug trials and research. Mene Research provides the excellent service due to TURKEY's UNIQUE opportunities ( High patient potential, High qualified site staff and low cost), and also operates in most of the countries in Middle East, Europe, West Asia (Armenia, Azerbaijan, Cyprus, Georgia, Greece, Egypt Iran, Israel, Jordan, Kuwait, Lebanon, Qatar, Saudi Arabia, United Arab Emirates, Uzbekistan)more

We work to offer superior value services to advantage patients, customers, staff and government bodies through reliability, inventiveness and efficiency. We are experienced in business administration and dedicated to meeting your needs. Our goal is to monitor clinical trials, support researchers and plan, implement and market proprietary software for clinical studies.

Mene Research had a Regulatory inspection (system, procedures, SOPs) by the authority of MoH of the Turkish Republic Pharmaceutical General Directorate and accredited. Mene Research is the first CRO inspected and accredited by MOH of Turkey. Also it has been accredited with ISO 9001:2000 which extend to all departments and services of the company. This Quality Management System is monitored, maintained and improved through internal and external audits, evaluations and reviews.

 

Pharmaceutical Industry Regulatory Affairs

Mene Research provide reliable and economical advisory services on pharmaceutical industry regulatory affairs. We have particular experience in composing regulatory dossiers to meet applicable standards and regulations for Turkish registration.

Once a dossier has been compiled, we pass it to the customer for approval, submit, and track its progress with the regulating bodies, and liase with clients to clarify and resolve any queries.

We have a comprehensive understanding of regulatory affairs, and their effects on research and drug design, as well as the drive, experience and ability to ensure that products can be approved for marketing.

Clinical Trial Monitoring Visits

Mene Research offer site visits throughout the trial process to ensure that appropriate equipment is available, staff are sufficiently trained and prepared, and that the study complies with the relevant regulations. Clinical trial monitoring visits carried out by Mene Research include initial site initiation and qualification visits, interim visits and trial close-out visits.

Site qualification visits assess infrastructure, equipment and supplies, staff preparednes and facilities. Initiation visits focus on staff attendance, division of work, preparedness, awareness of study guidelines, criteria for selecting study patients and reporting of adverse events. Interim visits ensure that standards are maintained throughout the study and cover many different aspects of the trial. Particular issues are discussed as appropriate at each interim visit. Trial close-out visits perform essential checks ensuring that appropriate documentation is completed and retained, that study stocks are properly accounted for and regulatory bodies are informed.

Drug Warehousing / Logistics

An important consideration in designing a clinical trial is the storage of drugs and equipment. Mene Research offer a complete drug warehousing / logistics service, available either as a component of a larger project, or a independant service. The warehouses allow a choice of refrigerated, frozen and room temperature storage with 24 hour monitoring and internet based records. Logistics services also include temperature controlled transport and distribution. The authority MoH of the Turkish Republic Pharmaceutical General Directorate has accredited the process

Mene Research offer support for logistics, customs approval, stock control and returns. The company have an established distribution network allowing products to be delivered reliably, on time and in good condition.

Feasibility in Clinical Research

Mene research complete a full report on the feasibility of clinical research before entering into a project. This report may cover the frequency and spread, as well as characteristics and death rates for the disease under study. Feasibility studies are also used to determine the best venue and staffing before the trial can begin.less

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Experts

  • Dr. Tolga Mene

    Owner, Mene Research Contact Expert

    Dr. Mene has held a VP position in the Bulk Chemistry and Pharmaceutical industry for 10 years. He is the founder of Depot Meridian which provides clinical trial specific warehousing, holistic depot and logistic solutions for study supplies in Turkey.

  • Dr. Mene held positions in pharmaceuticals and international CROs such as, Head of Clinical Management & CEO. A founding partner of MENE RESEARCH, a Turkish CRO, est. 2003 and a Board Member of the Association of Clinical Research in Turkey since 2006.

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Mene Research
G.O.S.B Technopark 400
41480, Gebze
Turkey

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