Similar in many ways to the pharmaceutical industry, biotech companies develop medications and vaccines to cure or alleviate symptoms and enhance the quality of life of people. The fundamental difference between the two industries is that biotech companies use the processes of living organisms as they manufacture products or solve problems.
The identification and sourcing of DNA have helped the industry make great leaps. Biotech companies are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy, and marketing of drugs.
New biotech 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.
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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. Raland clinical compliance professionals provide an objective assessment of the clinical trial testing and administration processes.
Instead of an NDA, biotech products require a Biologics License Application (BLA) for approval. Once the BLA 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 biotech manufacturing and testing processes.
Raland is proud to list several of the top US-based biotech firms as our clients.
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