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Phase 1 Clinical Services
53 services found
Manufactured by:Quay Pharma based inFlintshire, UNITED KINGDOM
We are extensively involved in developing early clinical formulations and clinical manufacturing of First in Human trials. We can develop a formulation specifically designed to achieve your targets during the crucial first clinical evaluations of your ...
by:Cytovance Biologics based inOklahoma City, OKLAHOMA (USA)
Cytovance® Biologics provides extensive mammalian and microbial pharmaceutical R&D service offerings that are both stand-alone and cGMP-enabling. Services include cell line development using Freedom® CHO-S® (Life Technologies), microbial strain development using GeneGPS Codon Optimization Technology (DNA2.0) and Cytovance® Biologics' Keystone Expression System™, ...
by:Ardena Holding NV based inMariakerke, BELGIUM
The physico-chemical characterisation of your drug substance is the basis of a successful development program. Navigating through the pre-clinical phase is not an easy task. Many compounds fail in early phase development because they are not bioavailable. It is our job to use our pre-formulation development expertise to give your molecule the best chance of success. Our extensive package of ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
In late clinical phases, and as part of the establishment of your commercial supply, Patheon provides a complete validation package according to regulatory and cGMP ...
Manufactured by:BIOVECTRA based inCharlottetown, PRINCE EDWARD ISLAND (CANADA)
Our strong technical leaders drive projects throughout product life cycles—from early to commercial stages. They review methods and processes in-depth with our clients’ subject matter experts to map tailored development and commercialization paths, allowing us to improve the likelihood of success. Our nimble, phase-appropriate approach to pre-clinical and clinical material supply ...
by:Vetter based inRavensburg, GERMANY
Learn how we work with you to design a flexible, scalable, reproducible, and efficient manufacturing processes for your clinical ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
With speed and efficiency, evaluate the properties of your biologic for a clear understanding of the path to Phase I clinical studies and beyond. Patheon gives you access to the full breadth of advanced analytical technologies and preformulation ...
Manufactured by:AB2 Bio Ltd. based inLausanne, SWITZERLAND
AB2 Bio has developed the first and proprietary assay to detect and measure free IL-18 in body fluids, which gives us the capability of identifying diseases associated with free IL-18 levels. The assay could also be used as a companion diagnostic to select patients most likely to respond to treatment with ...
Manufactured by:Applied Pharma Research s.a. based inBalerna, SWITZERLAND
APR has a dedicated clinical department that is involved in all stages of the clinical trial program from designing protocols to supervision, monitoring and conduction of clinical studies. We work with a network of existing partners or those selected by our ...
by:Vetter based inRavensburg, GERMANY
Our experts provide the guidance, insight, and Vetter process documentation you need to prepare a Common Technical Document (CTD) for clinical trials of your injectable drug ...
Manufactured by:Sartorius AG based inGoettingen, GERMANY
A more seamless transition into the clinic. Complex biopharmaceuticals and advanced therapies can present challenges during preclinical development. When implementing an albumin-based solution, Albumedix can help avoid unnecessary complications in your preclinical testing by creating species-specific recombinant albumins to suit your preclinical models. Using our proprietary recombinant ...
Manufactured by:BioSensics LLC based inNewton, MASSACHUSETTS (USA)
BioSensics provides global operations services to optimize the delivery of BioSensics’ solutions throughout all phases of clinical studies and trials. Our experienced team delivers exemplary service and novel technology to improve data quality and save ...
by:Cytel based inWaltham, MASSACHUSETTS (USA)
Every year, sponsors hesitating to use a complex innovative clinical trial design routinely miss opportunities to optimize the speed, savings and probability of success of their clinical trials. Cytel's statistical consultants and data managers work in tandem with sponsors to ensure new medicines move forward with the right study ...
Manufactured by:RoosterBio, Inc. based inFrederick, MARYLAND (USA)
The path to IND approval for cell-based therapies can be challenging and time consuming with strict regulatory requirements. That is why RoosterBio provides Process Development Services to help you build clinical phase appropriate cGMP processes for your specific product needs. We have served many customers to streamline the path to clinical testing with our industry-leading hMSC bioprocess ...
Manufactured by:Forge Biologics, Inc. based inGrove City, OHIO (USA)
Plasmid DNA is an essential component of gene therapy development and the starting point of Forge’s idea-to-impact manufacturing services to accelerate gene therapy programs from preclinical through clinical and on to commercial manufacturing. Forge’s plasmid production with single-use systems incorporates seamlessly into our optimized AAV manufacturing process for increased ...
Manufactured by:Regis Technologies Inc. based inMorton Grove, ILLINOIS (USA)
Expedite your discovery-to-market timeline by partnering with Regis Technologies to produce your Active Pharmaceutical Ingredients (APIs) and intermediates. We are committed to advancing your projects from initial process development, scale-up development through final validation and commercial manufacturing. Partner with Regis to bring your regulatory starting material, pre-clinical, phase I-III ...
by:Biovian Oy based inTurku, FINLAND
Biovian is a One-Stop-Shop CDMO for bacterial and yeast-based production of Drug Substances and Drug Products. Our microbial production services include GMP production of recombinant proteins and plasmid DNA for vaccines. The microbial GMP-manufacturing unit of Biovian is equipped with state-of-the-art fermenters, harvesting equipment, and a choice of downstream purification capabilities. ...
by:HingeClinica based inPrinceton, NEW JERSEY (USA)
Our Clinical Data Management team has solid experience in Phase I to Phase IV clinical data management services. We are committed to providing the highest data quality, integrity, and security for our clients in meeting 21 CFR part 11, GAMP 5 and HIPAA requirements. Using industry-leading electronic data capture (EDC) technologies. We provides end-to-end clinical data management support from eCRF ...
by:North American Science Associates Inc.(NAMSA ) based inNorthwood, OHIO (USA)
The clinical phase can be the most time consuming, least predictable, most expensive, and most important part of your development effort. So we work smart from the start, saving you time and preventing costly do-overs by optimizing strategies and tools to guide you through. Our clinical experience encompasses a broad range of technologies, therapies, and indications. With a tight focus on ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Ascendia works with discovery-stage pharmaceutical companies to provide lab-scale formulations suitable for pre-clinical testing. We conduct pre-formulation assessments, bioavailability modeling, and formulation approach comparisons. We provide trial formulations suitable for animal studies, toxicology studies, and cGMP clinical trial materials for Phase I studies. At Ascendia, our core business ...