Applied Laboratories Inc. Established in 1984 as a regulatory consulting firm specializing in FDA submissions, Applied Laboratories, Inc. has evolved into a full-service contract manufacturer and packager. Applied Laboratories, Inc. is registered...
Aptuit As the global leader in integrated pharmaceutical development services, Aptuit's suite of capabilities and wealth of expertise will speed your drug development process from discovery to launch.
Our ongoing commitment to...
Ben Venue Laboratories, Inc. Ben Venue Laboratories is a leader in the manufacture of sterile injectable and cytotoxic products. Since its founding in 1938, Ben Venue has developed extensive capacity and scientific expertise in the field of sterile...
Biotest Laboratories Inc. Biotest Laboratories, Inc. was organized by Gregg A. Mosley in 1988 as a test laboratory for manufacturers of medical products.The cornerstone of Biotest Laboratories, Inc.'s relationships with our customers is to provide...
Cambrex Corporation API, intermediates, drug delivery, active pharmaceutical ingredients, high potency, controlled substances, high energy compounds, generics, small molecule, chiral technology, custom development, customer manufacturing,...
Catalent Pharma Solutions, Inc. Catalent offers a full range of product development services such as pre-clinical support, API development, analytical services, drug delivery development, clinical manufacturing, packaging, and regulatory consulting...
Clinical manufacturing
Our aseptic liquid formulation and filling facility is cGMP validated. We utilize segregated Class 100 aseptic filling suites, controlled manufacturing and...
Conforma N.V. Contract Manufacturing Organization. GMP and ISO 13485 certified. Production of non-sterile Liquids and Semi-solids (creams, gels, ointments, ...).
There are often problems implementing conventional methods of controlling particulate exposures during many pharmaceutical manufacturing processes. Pharmaceutical manufacturing processes tend to be less flexible than similar chemical manufacturing processes due to the high level of regulation within the industry (i.e., Food and Drug Administration (FDA)). In addition, because the products are ...
A database coupled to a statistical analysis program is an effective means for defining a control space, determining process capability of components, establishing specifications for components and drug product and potentially correlating leachable levels to component extractable levels.
Eywiesenstraße 5 88212 Ravensburg Germany
phone: +49-(0)751-3700-0 fax: +49-(0)751-3700-4000 e-mail: info@vetter-pharma.com www.vetter-pharma.com
Uncertainty in Process Control – The Limit of Setting Limits
Heston Hall/Carriage House · Suite 203 1790 Yardley-Langhorne Road Vetter Pharma International GmbH Yardley, PA 19067 Ravensburg, Germany USA
phone: +1-215-321-6930 fax: +1-215-321-6932 ...
It is a universal truth that research, development manufacture and formulation of potent active pharmaceutical ingredients (APIs) and products requires both “hardware” ( facilities, equipment and engineering controls) and “software” (programs, practices and procedures) to adequately protect personnel and the environment. When employing third party contracting organizations, there is a need to ...
While “going green” is a recent cliché, it is also a key factor to consider when developing a product or modifying a process. In today's economic climate, the regulated product manufacturer needs to perform a thorough cost-benefits analysis before considering such a change. The obvious benefit of going green is the environmental aspect. However, the potential competitive benefits need to be ...
In an era characterized by the need to continuously evaluate and bolster R&D pipelines, the increasing complexity and overall cost to develop and approve drug products, the trend toward genericization, and mounting pressures to both decrease prices and maximize profitability, the pharmaceutical industry has sought competitive advantage in lower cost manufacturing jurisdictions.
The ...
The core of any good clinical supply chain system is a supply management system that addresses all of the nuances of clinical supplies. Although Clinical Supply Management is often considered a back-office business unit for a sponsor, it is almost always on the critical path of the drug development process. The efficient, accurate and timely delivery of material to the investigators is critical ...
This paper documents a solution provided by DMC to one of its customers in the form of a vision inspection and data acquisition system. DMC is an engineering consulting company that provides custom software solutions for its customers. For this project the customer is a company that operates chemical plating processes for metal products. In this solution, a “smart” digital camera is set up and ...
On the surface, providing a specified humidity and temperature for stability testing may appear easier to achieve than the 5% RH and 2C ICH guidelines would seem to indicate. The ability to control humidity at 2% does not mean that you are safely within the 5% RH tolerance dictated by ICH.
The ability to produce a recording, display, or printout that is within a specified tolerance may not be a ...
Chemical categorization (or banding) of inherent toxicity and potency linked with defined safe work environments including exposure controls has become an integral component of assuring the health and safety of research workers and manufacturing personnel in the pharmaceutical industry but is not a substitute for quantitative risk assessment in the workplace.
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