The pharmaceutical industry develops, produces, and markets prescription and over-the-counter medications and vaccines to cure or alleviate symptoms and enhance the quality of life of people. Pharmaceutical companies may deal in brand or generic and are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy, and marketing of drugs.
New pharmaceutical products must be approved by the FDA as being both safe and effective which involves submission of an IND (Investigational New Drug) with sufficient pre-clinical data to support proceeding with human trials. Raland regulatory professionals have the knowledge and experience to navigate the submission filing process.
Click here to see the full range of regulatory support services we offer.
Following IND approval, candidate drugs move through three phases of human clinical trials. The final phase, Phase III, is typically a large study of efficacy performed in a representative sample of the intended patient population.
Once a New Drug Application has been approved, the drug is ready for GMP manufacturing, GLP testing, marketing, and human use. Raland GxP professionals have the knowledge and experience to guide and troubleshoot the manufacturing and testing process.
Click here to see the full range of GxP support services we offer.
Raland has assisted numerous pharmaceutical companies with navigating the myriad of challenges and regulations required to satisfy the entire drug development, production, and approval lifecycle.