Deliverables

 

This list is not complete, so if you have a document or report requirement and do not see it listed, contact Biotech Ink about it.

 

Regulatory Documentation

Full FDA submissions:

  • CTDs
  • BLAs
  • INDs
  • NDAs
  • PMAs

 

Clinical study material:

  • protocols and amendments
  • GXP audit reports
  • investigator brochures
  • reports
  • SAE and AE narratives
  • informed consent forms
  • PK and toxicology reports
  • drug labeling, package inserts

Process Sciences/Development and CMC reporting

Authoring and Editing Services

  • Biomedical manuscripts, and related materials such as tables, illustrations, and figures,  for publication in peer-reviewed biomedical and scientific journals, including discovery and preclinical stage materials
  • Abstracts and posters
  • Slides and presentations for professional meetings

Technical Writing

  • CMC and process science/development documentation including stability reports
  • SOPs
  • Working guidelines
  • MSDSs

Market Reports and Data Gathering

  • Competitive intelligence
  • Industry analysis and trend projections
  • Gathering of patent and product liability data and documentation for legal applications

Other Communication Materials

  • Clinical development plans
  • Varied conference presentation materials
  • PowerPoint shows and templates
  • Word templates
  • Web site content
  • Company style guides
  • Press releases
  • Slide kits
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