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Drug Delivery Applications Services In Usa New Jersey
2 services found
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
A 505(b)(2) drug development project represents a streamlined regulatory strategy for many pharmaceutical products today. The provisions of 505(b)(2) were created to avoid unnecessary duplication of studies already performed on a previously approved product. A 505(b)(2) new drug application contains full safety and effectiveness reports on the drug product, but allows information required for ...
by:Freyr Solutions based inPrinceton, NEW JERSEY (USA)
After years of successful clinical research, submission of documents for Health Authority (HA) review requires a specialized skill of clear and precise clinical report writing. Such clear and precise clinical writing aids reviewers to easily comprehend the technicalities of clinical research, as a single error in clinical documentation may prove risky and costly for organizations, causing delays ...