Advanced BioScience Laboratories, Inc ABL is a CRO and CMO that specializes in developing and advancing infectious disease therapeutics and vaccines into the clinic.
Davos Chemical Corporation We provide custom chemistry (novel raw materials, GMP intermediates, regulatory starting materials & APIs) and custom dosage forms (parenterals and orals), with supporting development, analytics, stability and regulatory...
Bachem Bachem is an independent, technology-based, public biochemicals company providing full service to the pharma and biotech industry. Bachem is specialized in the process development and the manufacturing of peptides and...
Pharm-Olam International Pharm-Olam International is a multi-national contract research organization offering a wide range of comprehensive, phase I-IV clinical research services to the pharmaceutical, biotechnology and medical device industries.
MasterControl Software MasterControl produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company’s...
Biotech was “born” in the 1970s. Since that time innovation by biotech pioneers has brought more than 200 medicines and vaccines to fruition for difficult-to-treat indications including oncology, HIV/ AIDs, diabetes, and immune disorders.
Biotech is poised to capitalize on the current challenges confronting Big Pharma: looming patent expirations on blockbuster medicines and a dearth of new ...
The Food, Drug and Cosmetic Act requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. A sponsor however will want to ship an investigational drug to clinical investigators in many states; it must seek an exemption from that legal requirement. The Investigational New Drug Application (IND) obtains this exemption from ...
To identify bacteria and fungi, pharmaceutical manufactures rely on curated, compliant and up-to-date libraries. Results of using a proprietary library, based on over 300,000 unknown organisms recovered from environmental monitoring programs, show a two-fold reduction in unidentified strains when compared to a commercially available library.
The approval by the Food and Drug Administration (FDA) of the first inhaled insulin combination product for treatment of diabetes represents a milestone in drug delivery. Exubera is an inhaled powder form of recombinant human insulin (rDNA) used in the treatment of adult patients with type 1 and type 2 diabetes and is the first new delivery option introduced since the discovery of insulin in the ...
How to Guide for Writing a Drug Master File Introduction A drug master file (DMF) is a proprietary document typically written by or for the manufacturer to protect manufacturing information, an intermediate, starting raw material, Active Pharmaceutical Ingredient (API), description of production site/s or for other special requests. Most often, DMF's are written to protect the manufacturing ...
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