Making your products
ready!

Get Started Our Services

About us

pharmAccel Consulting is established and engaged in the drug delivery device business providing valuable service to the pharmaceutical industry in the field of drug delivery systems intended for nasal, pulmonary, ophthalmic, oral/sublingual and topical applications. With an experience of twenty five years in the drug delivery device industry, pharmAccel Consulting delivers a dedicated service to support an accelerated entry into the market of the client's product.

  • Drug Delivery Systems
  • Medical Devices
  • Complete Products

Strategic Approach

Drug delivery devices represent more than functional primary packaging. The development and creation of a competitive new drug product using a delivery system is a combination of different activities.


A delivery device is far more than an instrument for the administration of the formulation. The device is part of the primary packaging, is part of the container closure, and is the vehicle to transport successfully the active medicine to the target. During the dispensing act the responsibility of the effect of the therapy switches to the device. Delivery devices for nasal and pulmonary applications require additional particular attention during development and production as their performance characteristic and its reliability has a crucial impact on the efficiency of the nasal or pulmonary delivery to the target site.


pharmAccel Consulting's strategy is to apply a holistic approach taking into account all relevant issues which contribute to a successful delivery system. The service consists of individual activity modules covering the delivery system itself and the corresponding commercial, scientific, technical and regulatory issues. The respective individual modules will be executed according to the customer's requirements and will form the final product.


pharmAccel Consulting balances marketing and R&D interests under pharmaeconomical considerations and actively contributes to an accelerated and efficient drug product development process.

Services

DEVICE STRATEGY

  • Assessment and definition of the requirements of delivery systems
  • Market research and analysis of the existing market
  • Standard delivery device vs. customized delivery device
  • Generation of intellectual property rights

DEVICE TECHNOLOGY

  • Evaluation of the appropriate dispensing technology
  • Evaluation of secondary add-on features
  • Investigation and implementation of existing technologies
  • Assessment of the feasibility
  • Technology transfer into a mass product

TECHNICAL SERVICE

  • Technical evaluation of integrity parameters
  • Material selection
  • Compatibility issues
  • Selection of appropriate closure, gasket and container
  • Stereolithographic prototypes

ANALYTICAL SERVICE

  • Performance characterization of dispensing systems
  • in-vitro Bioequivalence Studies for ANDA and Submission of Generics
  • Microbiological Evaluation of Preservative Free Systems
  • Development of test methods
  • Generation of test protocols
  • Harmonization and validation of test methods and equipment
  • Formulation support

REGULATORY SERVICE

  • Support in regulatory device issues in accordance with the current regulatory guidances of the EMEA and FDA
  • Generation of Drug Master Files
  • Generation of Design History Files

DOCUMENTATION DOSSIERS

  • Generation of dossiers for CE-marked “ready-to-market” products
  • Device CMC documentation for submission

CONTRACT FILLING

  • Evaluation of appropriate contract fillers
    • liquid
    • powder
    • aseptic filling

CONTRACT MANUFACTURING

  • Providing contract design and manufacturing service
  • Support in the realization of device IP’s

Contact Us

Address

Kurze Gasse 2, 78345 Moos, Germany
Your message has been sent. Thank you!