Pacific BioLabs Pacific BioLabs is a contract research organization (CRO) offering testing and research support services to its clients in the medical device, pharm/biopharm, and other industries. Specializing in the biological sciences,...
Covance Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance...
Biopharmaceutical Services
Customized and committed to clients large or small, Covance recognizes your development program is as unique as the products you bring to our facilities....
Biosafety Testing Services
Perform biosafety testing with Covance to ensure the quality of your product and your process. We can also help you characterize cell banks used in the...
cGMP Cell Banking Services
Covance offers complete cGMP master (MCB) and working (WCB) cell bank generation, storage and cell line biosafety testing. As one of the first CROs to...
cGMP Validation cGMP Validation provides full service Validation and GMP Compliance consulting services for the pharmaceutical, biotech, medical device, and medical diagnostic industries. cGMP Validation specializes in the preparation...
Keller Consulting Since 1998, Keller Consulting has assisted large and small scale companies globally meet their regulatory requirements. We have assisted companies in the pharmaceutical, OTC, API, cosmetic, health and beauty and natural...
GMP Learning Center Since 1993 GMP Learning Center has been working and helping companies improve individual competency, job performance and meet regulatory compliance requirements regarding employee/associate qualifications. Results impact...
Caliso We offer a full range of consulting services geared towards helping small and medium-size businesses and organizations achieve competitiveness, certifications and compliance to international standards and regulations. The...
Form Automatic Solutions, Inc. Form Automation Solutions, Inc. (FAS) is based in Addison, TX. FAS received its first order in 2004 to assist a Fortune 100 snack-food company in reducing paper-based data gathering processes in their manufacturing plants...
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 ...
Formulation is arguably the most critical—and challenging—component of biopharmaceutical drug development, second only to the molecule itself. Formulation's far-reaching consequences help sponsors satisfy the scientific, medical, and regulatory conditions for drug approval and, subsequently, support marketplace success.
A biopharmaceutical formulation consists of active pharmaceutical ...
In March 2006, six normal healthy volunteers participating in a clinical study in the UK were given an intravenous (IV) dose of an experimental immuno therapeutic as a part of an ascending single dose safety and tolerability study. Within a few hours of drug administration, all subjects exhibited severe reactions which progressed to multiple organ failure. As a result of the incident, regulatory ...
The ability to respond to ever-evolving consumer at- titudes, regulatory mandates, and scientic discov- eries requires that manufacturers keep their nger on the pulse of the analytical methodologies required to monitor product safety and quality. In light of the ever- growing number of food and supplement ingredients and complex formulations, the ability to detect unique com- pounds and quantify ...
Pharmaceutical manufacturing executives today are all too familiar with industry regulations such as Title 21 CFR Part 11 and current good manufacturing practices (cGMPs). However, many drug companies still struggle to comply with these and other U.S. Food and Drug Administration (FDA) requirements.
In 2008 alone, the FDA issued 43 warning letters to pharmaceutical companies for regulatory ...
Conducting comprehensive metabolism studies has long been an essential component of a preclinical drug development program. However, numerous factors — including the increased development of protein-derived drugs and the expanded interest in the role of metabolites in safety assessment — are having a significant impact on the regulatory mandates, scope of studies and methodologies employed. In ...
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.
Environmental monitoring programs require the rapid and accurate Environmental monitoring programs require the rapid and accurate id of microorganisms. Fungal species are typically identification f iiFl i til tifi ti identified microscopically or by sequencing the D1 D2 region of the py y qg g identified microscopically or by sequencing the D1-D2 region of the large ribosomal subunit and ...
Historically, vaccines are medicines that deliver or generate antigens that induce specic, active, and protective immunity against infectious diseases. Antigens stimulate the immune system to activate cells and organs that induce active immunity, characterized by production of antibodies (humoral immunity) and/or cytotoxic T-cells (cell mediated immunity). Vaccines “train” the body’s immune ...
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 ...
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