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IPS

Medical Device / Novel Dosage

Medical Devices and Novel Dosage forms cover a large variety of technologies, many of which are unique and do not have established industry practices in terms of facility and systems design. Our services provide cost effective solutions based upon our application of the latest technologies, technical expertise and our science- and risk-based approach.

Sampling of Our Experience with Drug Delivery and Product Technologies

  • Bone Augmenation Inhalation
  • Bone Graft Substitutes
  • Dental Implants
  • Dermal Regeneration Products
  • Disposable Products
  • Drug Targeting
  • Fast-Dissolving
  • Gene Therapy
  • Genetic Delivery
  • Implants
  • Inhalation
  • Liposome
  • Medical Equipment Manufacturing
  • Metered Dose 
  • Modified Release
  • Mucosals
  • Needle-free
  • Neural Repair Products
  • Polymers/Biomaterials
  • Robotics/Assembly Systems
  • Sterlizing Systems
  • Site-specific
  • Soft Gel Capsules
  • Surgical Hemostats
  • Surgical Product Manufacutring
  • Sustained-release
  • Time-release
  • Topicals
  • Transdermal
  • Transmucosal

Having worked with many of the leading medical device and novel dosage manufacturers, we have successfully completed work on projects such as:  bulk / finishing facilities, packaging lines / systems, cleanrooms, laboratories, R&D facilities, manufacturing facilities, product development, offices, utility generation / systems and distribution and warehousing areas. 

Expertise in Facilities and Systems

  • ISO Quality System Consulting / Auditing
  • Quality System Regulations (GMPs)
  • Design Qualification
  • Risk Assessments
    • FMEA / FMECA
    • HACCP
    • Fault Tree / Fault Analysis
  • Lean Manufacturing
  • Design Controls
  • TUV Experience
  • PMA & 510K Assistance
  • CE Marking Assistance
  • Equipment, Surgical Systems, Electronics, Components, IVDs, Computer / Control Systems