Jordi Labs’ team of Ph.D. analytical chemists excels at helping companies worldwide comply with regulatory testing.
We offer these services for our regulatory clients (among others):
- Extractables & Leachables
- Medical Devices Testing
- Elemental Impurities
- Surgical Instrument Cleaning Analysis
- Efficacy Studies
- Cleaning Validation
- Compendial Testing
- Residue Analysis (EO, EC, EG)
- Storage/Stability Testing
- Accelerated Aging
- Forced Degradation
- Particulate Analysis
Here is a short list of some of the regulations we regularly work with:
- ISO 10993 Laboratory Testing Services
- FDA Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics
- FDA Guidance for Industry: Preparation of Premarket Submission for Food Contact Substances
- EPA Polymer Exemption Guidance Manual
- ICH Q2: Validation of Analytical Procedures: Text and Methodology
- ASTM F1980 Accelerated Aging Guidelines
- USP Raw Material Monographs
- USP Medical Device Monographs
- USP 232, 233, 2232
- USP 661, 661.1, 661.2
- USP 1663, 1664
We have specific experience with testing for European Union (EU) regulations:
- EN 13130 – Materials and Articles in Contact With Foodstuffs
- EN 1186 – Migration in Foodstuffs
- EU 10-2011 – Plastic Guidance With Food
Here are a few case studies from some of our previous regulatory work:
Please contact us to find out more about our range of regulatory testing experience.
Jordi Labs offers consultation services to assist our valued clients in designing possible synthetic strategies for their products.
A natural outgrowth of our product deformulation services has been the reformulation of products. This is generally a service we provide after deformulating a material.
Jordi Labs is a leading expert in polymer chemistry and polymer deformulation. Supported by over 30 years of successful polymeric resin development and polymer characterization, our organization is rich with a deep understanding of polymer systems from a synthetic and analytical perspective.
Jordi can provide literature searches and reviews from the viewpoint of an industry expert.
Jordi Labs’ chemists work with you to provide support throughout the patent life cycle.