Allay Pharmaceutical, LLC

Allay Pharmaceuticals, LLC is a company that supports pharmaceutical firms globally in bringing their products from initial concept to market readiness. They serve as a dependable outsourcing partner, offering a range of services that include product development, analytical services, regulatory compliance assistance, and various technical services. Clients can choose from standalone services or integrated solutions tailored to their specific requirements. The company prides itself on its team of skilled professionals, whose collective experience spans 15 to 35 years in the pharmaceutical sector. This expertise has led to over 250 Abbreviated New Drug Applications (ANDAs) being approved and the successful development of numerous New Chemical Entities (NCEs) along with the production of Clinical Trial Materials under current Good Manufacturing Practices (cGMP). Allay Pharmaceuticals provides comprehensive regulatory and compliance support, which encompasses the filing of Investigational New Drug applications (INDs), New Drug Applications (NDAs), ANDAs, addressing FDA deficiencies, and preparing for site pre-approval inspections. They cater to a wide array of clients worldwide, acting as regulatory agents to facilitate the registration of facilities and products with the U.S. Food and Drug Administration (FDA) and international health authorities. Additionally, their Technical Service Group offers on-site assistance to tackle manufacturing process challenges and provides consultation for the qualification of equipment and laboratory instruments. The company operates a facility that is registered with the FDA and adheres to cGMP standards, supported by an independent Quality Assurance program. Allay Pharmaceuticals is committed to addressing complex drug development challenges efficiently and accurately, aiming to achieve high levels of customer satisfaction.

Driving directions from: