gallery/logo triumpharma

 DatA Managment


     

 Pharmacy Services

Early Clinical drug development

quality assurance and training 


     

Regulatory Services


     

Clinical Project MAnagment

 


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 bioanalytical Services


     

Central Laboratory


     

Triumpharma’s goal is to achieve a leadership position in the bioanalytical sector through its commitment to serve excellence and technical expertise. All regulatory testing are conducted in accordance with GLP standards and internal SOPs.

Triumpharma has its own medical screening lab, located in Amman-Jordan, for safety samples analysis of studies conducted by Triumpharma.

The laboratory is able to perform general tests including biochemistry, hematology , immunology , endocrinology and routine tests. The laboratory is working under Triumpharma’s quality system and is periodically inspected by Triumpharma’s  quality assurance staff.

The Project Management unit (PMU) act as the liaison between the Sponsor, team members including local and regional CRAs, and sites while managing projects to ensure a service of the highest quality. Responsibilities encompass the overall management of a project including timeline adherence, internal and external communications, and project deliverables.

The data management unit’s  expertise within the pharmacology and pharmacokinetics fields as well as its knowledge of regulations requirements is the key to prepare clinical studies designs and protocols. The data management unit provides scientific support during the conduct of studies. Its role is to calculate & evaluate the study results and is involved preparation of final reports.

The pharmacy unit has a limited access room controlled for temperature and humidity. Triumpharma has a Drug Import License for all drugs types including (Narcotic drugs). The pharmacy is managed by qualified pharmacists trained on drugs handling procedures. Triumharma is well experienced in IMPs custom clearance and related JFDA and international roles and instructions.

We provide regulatory services (for clinical trials, PK/PD/BA/BE studies, and for preparing regulatory dossiers) to various major pharmaceutical companies & clients.

Our regulatory affairs and JFDA liaison staff is dedicated, well trained, and familiar with JFDA regulations and Laws, as well as international and ICH requirements.

Our clear and good understanding of Jordanian and international regulatory requirements and anticipations of questions that regulatory authorities may ask swift and speed up approvals.

Triumpharma has an independent functional quality assurance department dedicated for rigorous inspection of all aspects of GCP, GLP and cGMP compliance,The QA set ups the quality system of Triumpharma and assists in the continuous development, implementation and maintenance of the quality system to assure the availability of an up-to-date regulated environment. QA is involved throughout clinical study conduction procedures and provides full inspection covering all stages of the study,The quality assurance expertise provides a thorough revision of final reports with high scrutiny to nullify errors thus saving precious time in registration and avoid unnecessary loop cycles.

The QA also  provides internal and external training services (seminar, workshops, ...etc) by qualified and accredited staff.

 

 

Some of the key services that are offered by Triumpharma are Bioequivalence and bioavailability studies that are used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.Triumpharma has successfully conducted different types of BE/BA clinical trials since 2002. These studies have been performed on both healthy subjects and patients, awith various types of drugs and formulations including: Modified release tablets/capsules, complex injectables, conventional tablets/capsules, creams/lotions/Ointments, Orodispersible tablets (ODT), Inhalers and others dosage forms.The Studies performed for world global market submission include: Jordan, USA, Europe, Canada and MENA (the Middle East and North Africa) markets.