DrugDel Consulting, LLC provides a full range of services for technical and product development support, strategic planning and scientific/medical writing to the pharmaceutical and medical device industry, with particular emphasis on development of drug delivery systems and sustained or controlled release devices and dose forms.
Services include:
Drug Delivery, Formulation and Medical Device Consulting
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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
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MEDICAL DEVICES
- Implants
- Injectors
- Delivery devices
- MEMS devices
- Applicators
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FORMULATION RESEARCH & DEVELOPMENT
- Solutions and suspensions
- Capsules and tablets
- Gels and ointments
- Liposomes and emulsions
- Sprays and creams
- Proteins, peptides, insoluble compounds
- Formulating, sterilization, stability
- Packaging selection, identification or problem resolution
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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
- Competitive landscape analysis
- Preclinical feasibility and proof-of-concept planning
- Project tasking and timelines
- Project lifecycle planning
- Organizational structuring
- FTE and budgetary resourcing
- Business and marketing strategy
- Legal testimony
- Keynote speaking
- Promotional presentations
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Technical Writing, Authoring, Searching
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- CMC-Preclinical-Clinical-Regulatory Documentation
- Technical Reports
- IND
- IDE
- NDA
- PMA
- CE Tech File
- SOPs
- Protocols; stability/preclinical/clinical (GLP/GCP)
- Publications
- Patent disclosures
- Literature and patent searches
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