Superlative Biosciences LLC

About Us

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, medical devices 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 Diagnostics, 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/GCP, FDA/GTP, FDA/QSR, FDA/GMP, ICH, EMA, MDD/MDR, IVD/IVDR, CE Marking & ISO Documents Management


Preparation of SOPS, Master Batch Records (MBRs), CMC and Validation


FDA Filings (CBER or CDER) & Inspections


♦ Other Business Services Provided Are:

Technology Evaluation

Writing of Market Reports

Preparation of Business Plans 

Preparation of Marketing Plans

Writing of Biotechnology & Biomedical Articles and Online Study Guides

♦ We Also Help Companies Prepare Small Business Grant Applications and Handle Their Submissions:

SBIR and STTR Awards to the United States NIH, NSF, FDA, CDC, EPA, DOD, DOT and DHS

Renewable Energy Grants Preparation and Writing


Preparation of Supplies or Services Contract Proposals to All Agencies


Grant Writing to US and International Private Foundations