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Drug Master File Document Production Services In Usa Massachusetts
9 services found
by:Revvity Gene Delivery (formerly SIRION Biotech) based inHamburg, GERMANY
At Revvity, we work with you to expedite the development of gene therapy vectors. ...
by:Pace Analytical based inRoseville, MINNESOTA (USA)
Pace® Life Sciences has decades of practical formulation development experience and expertise with sterile and non-sterile products, oral or topical dosages. Our attention to detail helps us create an appropriate formulation for your drug product that is safe, pure, and effective. Our formulation strategies will withstand FDA scrutiny and accelerate the successful commercialization and launch ...
by:Pace Analytical based inRoseville, MINNESOTA (USA)
From early strategy discussions and meetings with agencies to submissions and applications support on through commercialization, we help our clients with regulatory, compliance, validations, training, and auditing support. Our understanding of domestic and international biotech and pharmaceutical operations and of the regulatory challenges facing these industries allows our experts to provide ...
by:Pace Analytical based inRoseville, MINNESOTA (USA)
With more than 20 years of experience in pharmaceutical research and manufacturing, we understand the specific challenges aseptic fill-finish and manufacturing presents. Our facility is carefully designed with the flow of personnel and materials in mind, which follows current Good Manufacturing Practices (cGMP) guidelines and minimizes contamination or mix-ups. Flexibility is important during ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
Active Pharmaceutical Ingredients (APIs) are substances or mixtures employed in the production of drugs. They have pharmacological effects or directly contribute to diagnosing, treating, mitigating symptoms, controlling, or preventing diseases, in addition to influencing the structure or function of the body. ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
Generic peptide pharmaceuticals are products that replicate existing peptide drugs. These drugs are typically composed of amino acids linked by peptide bonds and are used to treat a variety of diseases, including cancer, diabetes, and immune disorders. Developing these generics requires comprehensive research into synthesis processes, formulation technologies, quality control, and bioequivalence ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
Biopharmaceutical stability analysis is crucial for assessing the safety, efficacy, and quality of biopharmaceuticals throughout their storage, transportation, and usage. This analysis evaluates changes in the chemical, physical, microbiological, and biological properties of the ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
Urine contains a vast array of chemicals, including microbial metabolites and mammalian metabolic products. Drugs, pollutants, and industrial chemicals may also be present in urine. Since urine lacks homeostatic regulation, it can reflect metabolic disturbances, providing insights into systemic changes in response to physiological challenges or disease ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
Peptides are compounds formed by multiple amino acids linked by peptide bonds and can be prepared via recombinant DNA expression, biological extraction, or chemical synthesis. Peptides represent a unique class of drugs with certain characteristics of small molecule drugs as well as properties of large proteins and other biologics. Most intrinsic signaling molecules are peptide-based, such as ...