Ophthalmic & Ocular Formulation and Drug Delivery Technical Services

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


Alan L. Weiner, Ph.D.


DrugDel Consulting, LLC is a pharmaceutical consultancy that provides a full range of technical and regulatory advisory services for the development of ophthalmic or ocular dose forms and products with particular emphasis on creating effective, stable and safe formulations and controlled release systems. Services include inventive inputs and IP guidance, full life-cycle project planning, management of 3rd party contract services or strategic partners, and technical and regulatory documentation.



©Copyright 2016 DrugDel Consulting, LLC



Development of Formulations and Delivery Systems

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DRUG DELIVERY SYSTEMS
  • Inserts and implants
  • Active and passive release systems
  • Reservoir and matrix devices
  • Nano and micro systems
  • Targeting applications
MEDICAL DEVICES
  • Implants
  • Injectors
  • Delivery devices
  • MEMS devices
  • Applicators
FORMULATION RESEARCH & DEVELOPMENT
  • Solutions and suspensions
  • Capsules and tablets
  • Gels and ointments
  • Liposomes and emulsions
  • Sprays and creams
  • Proteins, peptides, nucleic acids, insoluble compounds
  • Formulating, sterilization, stability
  • Packaging selection, identification or problem resolution

Strategic Planning, Business Development, Technical Services

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  • Technology evaluations for venture or investment firms
  • Business plans
  • Incubator set up for startup, or growing companies
  • Preclinical feasibility and proof-of-concept planning
  • Project tasking and timelines
  • Project lifecycle planning
  • Organizational structuring
  • FTE and budgetary resourcing
  • Business and marketing strategy
  • Keynote speaking
  • Promotional presentations

Technical Writing, Authoring, Searching

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  • CMC-Preclinical-Clinical-Regulatory Documentation
    • Technical Reports
    • pre-IND briefing documents
    • IND
    • IDE
    • NDA
    • 510K
    • PMA
    • CE Tech File
  • SOPs
  • Protocols; stability/preclinical/clinical (GLP/GCP)
  • Publications
  • Patent disclosures
  • Literature and patent searches

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Copyright 2010 | DrugDel Consulting, LLC | All rights reserved.