Superlative BioSciences

About Us


Superlative BioSciences 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

 

♦ 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 

 

 

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