EUA Consultant will help you determine if the EUA is the right path for your device. We will help you to prepare for EUA filing and help you explore the EUA filing process and meet regulatory requirements under the EUA and after the COVID-19 outbreak. Preparation and submission of the EUA: Implementing an Emergency Use Authorization…
Start Up, New Molecular Entities (NME) and New Chemical Entities (NCE) are high quality, affordable products that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective and consistent compilation of NME & NCE Product and Process Development for…
Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective and consistent use and application of Data Standards can reduce costs of…
The FDA expects and requires that Sterile Injectable Products adhere to strict FDA standards pertaining to quality, purity, safety, and efficacy. As a result, Patients and Physicians rely upon and trust that the Injectable Products they administer adhere to the same high standards. The cGMP Injectable Product Manufacturing process is generally the primary place where…