The Solvay Injectables Regulatory Affairs Department is available to assist you where needed. We have experience with products evaluated by:

• The Center for Drug Evaluation and Research (CDER)
• The European Agency for the Evaluation of Medicinal Products (EMEA)
• The Canadian Health Protection Branch (HPB)

Solvay Injectables can also offer you assistance with the preparation of:

• Investigational New Drug Applications
• New Drug Applications and Updates
• Drug Master Files
• Biologic License Applications

Solvay Injectables maintains its Site Master Files and authorizes access to FDA Drug Master Files as needed. We also provide regulatory support in the preparation of international filings in many regions around the globe.

Our Quality Assurance department is responsible for releasing your batch records in full compliance with cGMP and FDA and EU requirements. Our facilities manufacture products that have been approved by the FDA, the Dutch Health Authorities on behalf of the European Agency for the Evaluation of Medicinal Products (EMEA) and the NIHC.

Solvay: a passion for progress with an eye to your future