This Is A Custom Widget

This Sliding Bar can be switched on or off in theme options, and can take any widget you throw at it or even fill it with your custom HTML Code. Its perfect for grabbing the attention of your viewers. Choose between 1, 2, 3 or 4 columns, set the background color, widget divider color, activate transparency, a top border or fully disable it on desktop and mobile.

This Is A Custom Widget

This Sliding Bar can be switched on or off in theme options, and can take any widget you throw at it or even fill it with your custom HTML Code. Its perfect for grabbing the attention of your viewers. Choose between 1, 2, 3 or 4 columns, set the background color, widget divider color, activate transparency, a top border or fully disable it on desktop and mobile.

Development Services for Injectable Delivery Systems

//Development Services for Injectable Delivery Systems
Development Services for Injectable Delivery Systems 2017-12-01T23:10:58+00:00
  • Injectable-Delivery-Systems-HPLC

Focused Analytical Services

Our team engages with customers to define the characteristics of elastomeric component that are best suited your drug product. We will assess functionality for intended use, extractables and leachables, and physical chemical compatibility. We provide dedicated support for migration studies with placebo or active drug to help you identify potential leachables and to optimize your formulation. We keep progress moving forward through stability studies, regulatory approval and post-market approval.

Request a Quote
Download Brochure

Product Life Cycle Support

Instrumentation

  • LC-MS
  • GC-MS
  • GC-HS
  • HPLC-UV
  • HPLC-PDA
  • UPLC
  • Ion Chromatography
  • ICP-MS
  • FTIR
  • Polarized Light Microscope
  • HIAC
  • Raman/LIBS
  • SEM-EDS

Compment Reference

  • Coated Stoppers

  • 13 & 20 mm stoppers

  • Serum stoppers

  • Lyophilzation stoppers

  • Ready to use

  • Ready to sterilize

  • UDS stoppers

  • Plungers

Qualifications

  • cGMP compliant laboratory, ISO 17025 Accredited and EQFAR certified laboratory through ANVISA
  • Registered with FDA (last inspection January 2016 – no 483s)
  • DEA license for controlled drug substances (schedule II-V)
  • Subject matter experts in:
    • Analytical chemistry
    • Extractables and leachables
    • Device expertise
    • Particle size analysis

Regulatory Experience

We have a proven track record of working with regulatory agencies to ensure a higher product approval rate.

  • FDA Guidance Container Closure Systems for Packaging Human Drugs and Biologics 1999
  • FDA Guidance Analytical Procedures and Methods Validation for Drugs and Biologics 2015
  • ICH Q3D Guideline for Elemental Impurities
Learn More