Ophthalmic & Ocular Formulation and Drug Delivery Technical Services

Contact Us

Ophthalmic and Ocular Consulting:
Drug Delivery | Formulations | Medical Devices


Alan L. Weiner, Ph.D.


Technical Writing


Drugdel Consulting, LLC offers a wide scope of technical authoring and documentation for ophthalmic pharmaceutical and medical device development, inclusive of drug delivery systems.

RESEARCH AND DEVELOPMENT


  • Stability protocols
  • Preclinical protocols
  • Clinical protocols
  • CMC technical reports
  • Drug/device master files
  • Batch/lot record templates
  • Preclinical study reports
  • Investigator Brochures
  • Investigator Agreements and Financial Disclosures
  • Clinical study reports
  • Design control documentation
  • Risk management documentation
  • Standard operating procedures (SOPs)

SCIENTIFIC AND PROMOTIONAL


  • Publications: articles and abstracts
  • Meeting poster presentations
  • Patent disclosures
  • Drug monographs
  • Promotional brochures and handouts
  • Formulary dossiers and managed care literature
  • White papers and internal reference documents
  • Sales training documents

REGULATORY APPLICATIONS


  • Briefing Packages: IND, IDE, PMA, NDA
  • Clinical Trial Applications: IND, IDE
  • Drug/Device Applications: NDA, 505(b)(2), ANDA,(510)(k), PMA, CE Mark
  • Amendments and supplements
  • Annual Reports

BUSINESS AND STRATEGIC


  • Business plans
  • Strategic plans
  • Contract development
    • Vendor
    • Research licensing
    • CRO
  • Grant applications
Copyright 2010 | DrugDel Consulting, LLC | All rights reserved.