Pfizer CentreSource (PCS) has a Regulatory Affairs team dedicated to writing and maintaining regulatory agency filings that meet current International Conference on Harmonization (ICH) standards.
Current programs are in place to address ICH standards for stability, impurities, residual catalysts/heavy metals, and residual solvents across all Active Pharmaceutical Ingredients PCS sells.
Pfizer has 68 type II DMFs in the U.S. In addition, Pfizer has 119 DMF type files in 21 countries throughout the European Union and including Canada, Australia and New Zealand.
Pfizer holds a COS for:
- Estradiol Hemihydrate
- Spironolactone
- Prednisolone
- Dexamethasone Sodium Phosphate
- Neomycin Sulfate
- Dexamethasone
Dossiers are under review by the European Directorate for Quality Medicines (EDQM) for:
- Hydrocortisone
- Hydrocortisone Acetate
Dossiers will be soon be submitted for:
- Progesterone
- Prednisolone Sodium Phosphate
- Testosterone
- Megestrol Acetate
In addition, PCS holds 52 Transient Spongiform Encephalopathy (TSE) Certificates of Suitability.
We welcome the opportunity to learn about your pharmaceutical product development needs and challenges. Please contact us to explore how Pfizer's strengths and experience can exceed your goals.
For product-specific information, please visit the products section of our website.