Jupiter Global Bio-Research Inc.
Jupiter Global Bio-Research Inc.
  • Home
  • About
  • Services
    • Clinical Trials
    • FSP Model
    • Project Management
    • Site Management
    • Corporate Training
    • Procurement & Logistics
    • IVRT-IVPT Studies
    • In Vitro Feeding Tube
    • In Vitro Binding Studies
    • BCS Bio-waiver studies
    • Extractables & Leachable
    • Method Development
  • JUPITER ACADEMY
    • CLINICAL RESEARCH
    • RISK-BASED MONITORING
  • Career
  • Contact Us
  • More
    • Home
    • About
    • Services
      • Clinical Trials
      • FSP Model
      • Project Management
      • Site Management
      • Corporate Training
      • Procurement & Logistics
      • IVRT-IVPT Studies
      • In Vitro Feeding Tube
      • In Vitro Binding Studies
      • BCS Bio-waiver studies
      • Extractables & Leachable
      • Method Development
    • JUPITER ACADEMY
      • CLINICAL RESEARCH
      • RISK-BASED MONITORING
    • Career
    • Contact Us
  • Home
  • About
  • Services
    • Clinical Trials
    • FSP Model
    • Project Management
    • Site Management
    • Corporate Training
    • Procurement & Logistics
    • IVRT-IVPT Studies
    • In Vitro Feeding Tube
    • In Vitro Binding Studies
    • BCS Bio-waiver studies
    • Extractables & Leachable
    • Method Development
  • JUPITER ACADEMY
    • CLINICAL RESEARCH
    • RISK-BASED MONITORING
  • Career
  • Contact Us

About Jupiter Global Bio-Research Inc.

 Jupiter Global Bio-Research is your trusted partner in innovation. With our global network of experienced research team, we offer comprehensive solutions for all your clinical research needs. From end-to-end clinical trials to data management and statistical analysis, we're committed to delivering exceptional results. 

Our Broad Range of services

Clinical Trials

Functional Service Provider

Functional Service Provider

 Conduct rigorous clinical trials to evaluate new drugs or medical devices. Our experienced team follows established protocols and adheres to ethical guidelines to ensure the well-being of study participants. 

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Functional Service Provider

Functional Service Provider

Functional Service Provider

 Offer tailored services on a contract basis to meet specific needs. As a trusted FSP, we provide flexible and cost-effective solutions for a wide range of clinical research activities. 

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Project Management

Functional Service Provider

Project Management

 Oversee and coordinate clinical trial projects, ensuring timely completion and quality. Our experienced project managers utilize effective risk management strategies and problem-solving techniques to address challenges and ensure project success. 

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Site Management

Procurement, Sourcing & Logistics

Project Management

 Oversee and coordinate clinical trial activities at study sites. Our experienced site managers ensure compliance with regulatory standards, monitor site performance, and manage site personnel and resources effectively. 

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Corporate Training

Procurement, Sourcing & Logistics

Procurement, Sourcing & Logistics

Our experienced trainers offer comprehensive training programs to your site staff and company employees, covering essential guidelines and regulations like ICH, GCP, GLP, Protocol training, and Study Specific Training. 

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Procurement, Sourcing & Logistics

Procurement, Sourcing & Logistics

Procurement, Sourcing & Logistics

 Efficiently manage supply chains, source quality materials, and ensure timely delivery. Our team of experts works closely with suppliers to identify and procure high-quality materials and equipment at competitive prices. We optimize supply chains to minimize disruptions and delays. 

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IVRT-IVPT Studies

In Vitro Binding Studies

In Vitro Feeding Tube

  •  In-Vitro Release Test (IVRT) 
  • In-Vitro Permeation Test (IVPT) Studies 
  • IVRT : In-vitro test with synthetic membranes 
  • IVPT: In-vitro test with Human Cadaver skin 
  • IVRT & IVPT Apparatus: Vertical diffusion cell (Franz Cell) 
  • Performed on Topical Formulation : Gel, Lotions, Ointment and Cream
  • Few USFDA PSG :Adapalene, Acyclovir, Clindamycin phosphate, Calcipotriene, Dapsone, Diclofenac sodium, Ivermectin, Mupirocin , Penciclovir, Silver sulfadiazine, Sirolimus, Tacrolimus, Tazarotene 

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In Vitro Feeding Tube

In Vitro Binding Studies

In Vitro Feeding Tube

  •  NG & G Tube Studies
  • Testing will be carried out in Drug Product which was Administration through feeding tube studies
  • Performed : Tablet Products, Oral suspension & capsules containing pellets, Granules or beads
  • NG Tube Apparatus: Tube, Tube Platform and Camera
  • Few USFDA PSG : Dexlansoprazole, Lansoprazole, Apixaban, Rivaroxaban, Gefitinib, Ticagrelor, Mycophenolate Mofetil, Baclofen, Carglumic acid, Baricitinib, Esomeprazole magnesium, Pantoprazole sodium, Omeprazole magnesium 

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In Vitro Binding Studies

In Vitro Binding Studies

In Vitro Binding Studies

  • Type of study: In-vitro equilibrium binding study
  • Type of study: In-vitro kinetic binding study
  • Performed : Powder, Suspension, Tablet
  • Few USFDA PSG : Cholestyramine HCl, Colesevelam HCl, Colestipol. Sucralfate Suspension and Tablet, Sevelamer Carbonate, Sevelamer HCl, Sucroferric oxyhydroxide, Ferric citrate, Lanthanum carbonate 

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BCS Bio-waiver studies

Method Development and Validations

In Vitro Binding Studies

  • BE waivers based on BCS can be applied for BCS Class I and BCS Class III
  • BCS Bio-waiver Caco-2 package
  • Drug Products : Solid oral dosage forms
  • Few USFDA PSG : Capacitabine, Imatinib, Cyclophosphamide, Ramelteon, Varenicline, Vigabatrin, Azacitidine , Temozolamide, Docusate sodium, Buspirone 

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Extractables & Leachable

Method Development and Validations

Method Development and Validations

  • Studies for Ophthalmic, Injectable, cream/ointments, Nasal Preparations etc.
  • Studies based on the concepts described by USP and PQRI recommendations
  • Expertise in protocol design based on packaging material

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Method Development and Validations

Method Development and Validations

Method Development and Validations

  • Expertise in method development for impurity profile, dissolutions, assay and residual solvents
  • More than 1400 method developments and validations completed with various guidelines
  • Methods for low level detection of genotoxic impurities e.g., NDMA, NDEA simultaneous
  • Methods for cleaning validations 

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