Regulatory Guidance on Biologics, Biosimilars, Pharmaceuticals, Human Cell or Tissue Based Products, Medical Devices, In Vitro Diagnostics, Combination Devices, Digital Health, Generative AI & ML, and Healthcare Blockchain Products.

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