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Drug Master File Document Production Services In Usa New Jersey
13 services found
Manufactured by:Cambrex Corporation based inEast Rutherford, NEW JERSEY (USA)
Cambrex provides a seamless method on-boarding process to establish robust methodology at our sites. We have extensive equipment capabilities that allow us to support full release and routine testing. ...
Manufactured by:ZebraSci Inc. based inTemecula, CALIFORNIA (USA)
The medical device community is continually faced with the challenge of providing patients with reliable solutions for drug delivery. One of the “go-to” delivery platforms are syringes. Glass or plastic syringes are often used in connection with Luer fittings for injection needles, adapters or transfer devices. Another common syringe platform is pre-filled syringes, filled with a ...
by:Solvias AG based inKaiseraugst, 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 degradation studies according to ICH guidelines Q5C and Q1B. ...
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (USA)
At Catalent Biologics, we understand the increasingly complex analytical and regulatory requirements for biologics and other large molecules and also new technologies and techniques that can be employed. We offer one of the broadest ranges of biologics and other large molecule analytical services in the industry, all under full CGMP compliance. Our biologics analytical services can be provided as ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
A 505(b)(2) drug development project represents a streamlined regulatory strategy for many pharmaceutical products today. The provisions of 505(b)(2) were created to avoid unnecessary duplication of studies already performed on a previously approved product. A 505(b)(2) new drug application contains full safety and effectiveness reports on the drug product, but allows information required for ...
Manufactured by:ZebraSci Inc. based inTemecula, CALIFORNIA (USA)
One of the many variables that contribute to drug delivery device reliability is the primary container itself. With our experience with the containers and components from the world’s leading manufacturers, we can assist you with selecting the right components or optimizing your device to an existing container. Leverage our knowledge, experience and partnerships to be well informed for ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Before conducting pharmaceutical drug product formulation activities, pre-formulation studies are initiated. During the pre-formulation phase, the physical and chemical properties of the active pharmaceutical ingredient (API) are determined. The knowledge gained on the API helps to select the right salt or polymorphic form, and supports the design and development of an initial dosage form, both ...
Manufactured by:Synbio Technologies LLC based in, NEW JERSEY (USA)
In recent years, the proportion of biological drugs in the global pharmaceutical market has been close to 20%. The focus within the global pharmaceutical market has been gradually shifting from small molecule chemical drugs to biomacromolecules (biological drugs). It also appears that the trend is gradually expanding. Biological drugs are a broad class of pharmaceuticals generated by using ...
Manufactured by:Minaris Regenerative Medicine, LLC based inAllendale, NEW JERSEY (USA)
Minaris Regenerative Medicine’s manufacturing development services help you to design efficient and robust manufacturing processes for your cell and gene therapy. Keeping the ultimate goal of commercial supply in mind, we help you think beyond your current manufacturing needs to create approaches that improve the commercial viability of your products. We keep in mind four key elements of ...
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (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 process and validation methods used to evaluate the drug product ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Parenteral formulation development for drugs delivered by injection or infusion is the fastest and the second most common route of drug administration. These formulations must achieve good compatibility of the drug substances with the excipients and the primary container. ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Parenteral formulation development for drugs delivered by injection or infusion is the fastest and the second most common route of drug administration. These formulations must achieve good compatibility of the drug substances with the excipients and the primary container. Successful formulation development can determine drug patentability, lifecycle, and overall market success. With growing ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (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 key position in the pharmaceutical market by ...