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.

Ophthalmic Drug Delivery Consulting
Ophthalmic Formulation Development Consulting
Ophthalmic Medical Device Consulting

Ophthalmic Drug Delivery Consulting

Dr. Alan Weiner, Principal Consultant, brings extensive expertise in the development of ophthalmic formulations and drug delivery systems. While he is noted for his work with ophthalmic systems,his delivery system experience, knowledge and capabilities include but are not limited to:
  • reservoir and matrix devices
  • eroding and non-eroding paradigms
  • active and passive mechanisms
  • pulsatile vs continuous delivery
  • polymeric systems
  • MEMS applications
  • refillable devices
  • remote activation
  • microspheres
  • nano technologies
  • lipid carriers
  • targeting modifications
  • injector systems
  • protein/petide slow release

DrugDel Consulting LLC provide clients with comprehensive consulting advice covering most drug delivery developmental areas across CMC, preclinical and clinical disciplines. Dr. Weiner can assist clients in navigating their way through new product design and implementation, proof-of-concept strategy, IND feasibility studies, longer term confirmatory studies and product lifecycle extensions.

Ophthalmic Formulation Development Consulting

DrugDel Consulting LLC will help clients to develop formulation or deformulation strategies for a wide range of different dosage forms. This includes API containing compositions with difficult to formulate compounds such as peptides, proteins, oligonucleotides and poorly soluble compounds.

Beyond the initial design, compositions must meet specifications narrow enough to satisfy regulators yet sufficiently broad to allow for manufacturability. Formulations also must be designed to comply with relevant territorial stability requirements (climate zones) sufficient for commercial utility. Dr. Weiner works closely with clients to help them maximize elegant formulation designs for performance and shelf-life as well as understand the applicable testing and stability program requirements from territorial compendia, ICH, ISO and MDD.

Formulation development consulting services include:
  • Material sourcing
  • Excipient development
  • Compositions and formula stabilization
  • Packaging selection or identification
  • Contract lab identification and agreements
  • Batch/lot records and documentation
  • Process optimization, validation and scaling
  • Specification development
  • Test method identification
  • API and product stability program setup
  • Accelerated testing and filing strategies
  • Stability data evaluation

Ophthalmic Medical Device Consulting

DrugDel Consulting, LLC guides clients through all phases of development of medical devices. We assist in solving the many potential challenges that arise throughout the development process of prototyping, bench and preclinical verifications, clinical validation strategies or regulatory path and approval.

We can help you with:

  • Design Control
  • Product Development/Commercialization
  • Risk Management Assessment
  • Device Classification, Applications and Submissions
  • Technical Documentation for 510(k), CE-marking, IDE, PMA
  • Selection/ Coordination with Notified Body
  • Regulatory Responses
  • Clinical Trial Design/Strategy
  • Labeling development
  • Medical/Marketing Communications

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