Drug Product Services
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based in NETHERLANDS
When you’re developing a finished dosage form, your project costs are most likely in a sound competition with your available funds. This is why choosing a CDMO is an important and long term decision. BioConnection can help you out with an oversight of the technology transfer and per-unit manufacturing cost. Let us also assist you with determining the often hidden costs: depending upon the ...
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based in BELGIUM
At Ardena, we guide our customers into making smarter formulation choices. Ultimately, this reduces the risk of clinical failure and ensures your product reaches the clinic rapidly via the most efficient route. Solving a problem and saving time Overcoming development challenges is our speciality. We work with customers to understand their ...
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Manufactured by CELONIC Groupbased in SWITZERLAND
We offer comprehensive Fill & Finish services for liquid-formulated drug products – from aseptic filling to QC tests, labeling, packaging, storage, and release. Our solution-driven GMP-complaint processes come with unparalleled flexibility, fully-adaptable to the unique needs of our clients. Having completed over 300 GMP filling ...
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Manufactured by Ascendia Pharmaceuticalsbased in USA
Biological formulation development involves discovering solutions for the most bioactive, native protein delivery. It poses a myriad of challenges due to the fact biologics consist of generally large, complex molecules that complicate drug development. Biologics are at the forefront of many current medical advances. They have established a ...
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Manufactured by CD Formulationbased in USA
In order to ensure the safety of drug product quality, the packaging system that comes into direct contact with the drug product needs to meet compatibility requirements. Compatibility studies refer to the process of evaluating packaging components or systems that are in direct contact with the drug ...
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Manufactured by Catalent, Incbased in USA
Drug product development can be a daunting and expensive process. Biotech companies face many hurdles along the way, including the development and optimization of a scalable, commercially viable formulation while ensuring safety and efficacy of the final drug product. In order to receive regulatory approval, the manufacturing ...
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based in USA
Drug product formulation development starts with an understanding of the drug substance. Our experts work with you to define and understand the anticipated use, desired performance criteria, characteristics of the drug product, distribution, storage, and ...
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based in USA
Supporting client requirements from creation to maintenance of global and local drug product labeling. Regulatory Labeling regulations are essential for ensuring compliance of drug products to be used safely and with efficacy by patients. However, regulatory labeling compliance requirements can differ across regions and new ...
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Manufactured by Advanced Microdevices Pvt. Ltd. (mdi)based in INDIA
Our microbial retention studies qualify the filter under test to repeatedly produce a sterile filtrate with the drug product under simulated worst case process conditions in accordance to: USFDA CDER guidance document on Sterile Drug Products Produced by Aseptic Processing. PDA Technical Report No. 26, Revised 2008 on Sterilizing ...
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based in CANADA
Nexreg can work with your company to develop drug product labels which meet Canadian requirements. As well, Nexreg's team of experts will complete the DIN Submission Certification form required by the Therapeutic Products Directorate (TPD) of Health Canada. The Drug Identification Number (DIN) is the number located on the label ...
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Manufactured by Advanced Microdevices Pvt. Ltd. (mdi)based in INDIA
We comprehend and value the critical importance of establishing drug product wetted integrity test specifications to ensure filter efficiency. The drug product / process fluid, due to different components, may have different surface tension than the filter manufacturer specified wetting fluid, impacting the drug ...
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based in USA
Depending upon the requirements of the drug product, a variety of filling conditions can be tested and equipment ...
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by Vetterbased in 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 ...
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Manufactured by ApiJect Systems, Corp.based in USA
Our device and BFS manufacturing experts will work with your team to fill-finish your drug product in one of our customized prefilled drug delivery systems at scale. ...
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Manufactured by Precision NanoSystemsbased in CANADA
Combining disruptive technology platforms with unparalleled genomic medicine development expertise, Precision NanoSystems’ Biopharmaceutical Services accelerates the development of lipid nanoparticle (LNP) formulations and drug products. ...
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based in USA
Lifecore’s analytical development team has broad experience with Compendial methods, transferring client developed test methods, and developing unique methods for assaying drug products and ...
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by Biovian Oybased in 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 ...
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based in USA
What are APIS and should I Be Concerned about Them? Active pharmaceutical ingredients (APIs) are defined as any substance or a mixture of substances that when used in the production of a drug, becomes an active ingredient in the drug product. Unlike most chemical hazards in the workplace for which health effects upon exposure are ...
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by Solvias AGbased in SWITZERLAND
We understand that early assessment of a protein biopharmaceutical’s stability can be invaluable, even during pre-development. For drug substances and drug products all stability aspects can be monitored including long term and accelerated stability studies, in use studies, short term temperature excursion studies, and forced ...
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based in GERMANY
In addition to offering an extensive portfolio of in-house developed generic drug products across indications, AET has started the development of biosimilars and innovative product designs. AET provides a comprehensive service from project concept (including global portfolio and IP strategy and competitive product design) via ...
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