Superlative BioSciences

Superlative Biosciences LLC serves as a professional consultant to companies actively developing medical products. We provide quality and regulatory consulting in the area of biologics, pharmaceuticals, human cell and tissue products, and in vitro diagnostics. Our goal is to help you to move your company's life sciences projects forward from conception to validation, through development, pass regulatory hurdles, and into the marketplace. Services That We Provide ♦ Superlative BioSciences Provides Consultation On: Biologics, Biosimilars, Pharmaceuticals, In Vitro Diagnotics, Cell & Tissue Therapy, Stem Cells, and Combination Devices Regulatory Guidance The Preparation of Quality Manuals & Other Quality Documents including Change Control, Deviations, CAPA, FMEA, Trending, and Complaint Handling, FDA/GLP, FDA/GTP, FDA/QSR, FDA/GMP, ICH, EMA, CE Marking & ISO Documents Management. Preparation of SOPS, Master Batch Records (MBRs), CMC and Validation FDA Filings (CBER or CDER) & Inspections ♦ We Also Help Companies Prepare Small Business Grant Applications and Handle Those Submissions.