Allay Pharmaceuticals LLC. 16600 NW 54th AVE, Unit #23, Miami, Florida 33014 , USA
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Regulatory & Compliance
Allay Pharmaceuticals, LLC is a pharmaceutical service company serving sponsors worldwide. We are your reliable outsourcing partner for quality and affordable product development, analytical services, regulatory and compliance support as well as technical services. We are a contract pharmaceutical service provider to US and foreign sponsors worldwide. From concept to commercialization, we can assist you every stage of the way. Whether you need a stand alone service or a combination of services, we can provide the solution that best fits your need.
Our most valued asset is our proficient scientists, whose combined expertise encompasses all aspects of pharmaceutical development and operations. Our team is comprised of experts who has extensive knowledge in the drug industry with specific
Our facility is registered with the Food and Drug Administration (FDA). We operate within current Good Manufacturing Practices (cGMPs) and have an independent Quality Assurance program for our operations.
Our regulatory and compliance support services include but not limited to, filing of INDs, NDAs, ANDA, resolution of FDA deficiencies and site pre-approval inspection readiness. We serve a diverse group of clientele globally as regulatory agents to assist with the registration of facilities and their products with US FDA and other Foreign Health Ministries around the world. Our Technical Service Group We also provide on site technical services to resolve manufacturing process issues and consultation for qualification of equipment and laboratory instruments. The experience profile of our scientists ranges from 15-35 years with over 250 ANDA approvals and hundreds of successful formulations of NCEs developed and cGMP Clinical Trial Materials manufactured.