Process validation is a critical regulatory requirement in pharmaceutical manufacturing. It ensures that a production process consistently yields products of predetermined quality and safety. The goal is to verify that all stages of drug production—from raw materials to final dosage...
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For drug developers the 505(b)(2) pathway presents an expedited pathway to FDA approval. In our experience, the conversation on 505(b)(2) pathways commonly focuses on predicate data or bridging strategies to accelerate FDA approval but lacks dialogue on the needs of...
Inhaled combination products (ICP) have emerged as a significant advancement in the treatment of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary conditions. Inhalation offers a targeted route of drug delivery directly to the lungs,...
In today’s fast-paced world of scientific discovery, cutting-edge technology is revolutionizing the way we approach complex biological problems. One such innovation is in silico modeling, a method that harnesses the power of computer simulations to model biological systems. But what...
In recent years, advanced manufacturing has gained traction in the pharmaceutical industry, transforming how drugs are developed, produced, and delivered. It is recognized, however, that there is a learning curve across the industry and FDA that is inherent to the...
Accelerated approval is an expedited regulatory pathway designed to hasten the availability of drugs (including biologics) that treat serious conditions, offer advantages over existing therapies, and address unmet medical needs. The FDA defines a serious condition as “a disease or...
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Inspection Readiness Program
The Premier Research Quality Assurance (QA) team has developed a unique definition of inspection readiness that is not only inclusive of an organization’s quality culture and continuous improvement mindset but also is applicable across cGxP regulations. The Premier Research’s definition...
The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. Unlike the traditional...
The 505(b)(2) pathway offers a strategic avenue for pharmaceutical companies to bring qualifying drugs to market more efficiently. By understanding and optimizing this pathway, companies can expedite drug development, minimize risk, and maximize return on investment, ultimately accelerating the delivery...
As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. The major markets follow ICH guidelines, which affords...