Business

Chemistry, Manufacturing, and Controls (CMC) E&E Medicals, a leading player in centralized Chemistry, Manufacturing and Controls (CMC) lifecycle management for Regulatory submissions, offers services for CMC Regulatory affairs. Our streamlined regulatory CMC support process Step #1: To kick off our collaboration, we take the time to grasp your requirements and objectives fully. This will allow […]

The US Food and Drug Administration (FDA) neither requires nor discourages the submission of Drug Master Files (DMFs). Manufacturers and DMF holders must submit separate DMFs for drug substances, excipients, and packaging materials to ensure patient privacy. DMF holders are responsible for ensuring that their DMF satisfies all FDA requirements, including those pertaining to the […]

Through the BLA, promising biological medicinal products can be developed and approved to prevent and treat a wide range of serious, chronic diseases and conditions. That is why biopharma companies are working on new biological products to fill a void in the healthcare industry. Applicants face a difficult decision when deciding on a development strategy […]

The Abbreviated New Drug Application (ANDA) is the pharmaceutical industry’s entry point for generic medicines to demonstrate their therapeutic equivalence to innovator/branded drugs in terms of quality, safety, and efficacy, making them a more affordable option. US officials are aware of the potential of the generic medicines market, so they push for the growth of […]

The United States Food and Drug Administration (FDA) approves pharmaceutical drugs for human use through the New Drug Application (NDA) 505 b (1) and 505 b (2) application process (US FDA). There are two routes for new drug approval established by law in the United States: the 505(b)(1) NDA pathway and the 505(b)(2) NDA pathway. […]

To transport or distribute a drug across the United States for use in a clinical program, the sponsor must first submit an Investigational New Drug Application (INDA) to the US Food and Drug Administration (FDA) and receive Agency acceptance. The US Food and Drug Administration (FDA) may place a Clinical Hold (full or partial clinical hold) on an […]