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.
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
Component Reference
Coated Stoppers
13 & 20 mm stoppers
Serum stoppers
Lyophilized 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