Pharmaceutical Translations Compliant with Industry Standards
DIN EN 15038. Try our services. Pick up the phone and call or e-mail us today!
Traditionally, the pharmaceutical products range is limited to the veterinary and human medicine market segments. These segments manufacture and offer on the market an exceptionally large variety of brand and generic medicinal products. Particularly important among them are the finished medicinal products, various sera, blood formulations, and the so called in vivo diagnostics, and allergen preparations. In recent years, the pharmaceutical industry developed a whole new product area resulting from the achievements of medical research, for example, gene therapy, biotechnologically derived tissue, and mass quantities of manufactured cell therapy products. The pharmaceutical products range also includes medical devices. Among them are, for example, artificial joints, heart valves, glass eyes, prostheses, dressings, catheters, and in vivo diagnostics tools of the kind provided by the pharmaceutical industry only.
Pharmaceutical Industry Regulatory Framework
The U.S. Pharmaceutical industry is regulated by the FDA. Most medicinal products require approval by the FDA before they can be released on the market. Companies in the Pharmaceutical sector obtain those approvals and bring drugs and medical devices on the market under their brand names. The sale of drugs and other medical products requires special authorization that is subject to certain terms and legal restrictions. To ensure the safety, efficacy, and quality of all pharmaceutical products, pharmaceutical companies are subject to certain national standards. These include pre-clinical and clinical testing of all products, quality control systems, and a system of pharmacovigilance, which makes timely discovery of undesirable side effects of pharmaceutical products possible. Similarly, pharmaceutical translations are also subject to strict requirements. This is why you should only have your documents translated by experienced professionals with relevant subject matter expertise. We will be happy to provide you with more information upon request. Give us acallor email us. We look forward to your call!
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