Are You Following Regulations?
As a pharma manufacturer, it can be challenging to stay up to date with the ever-changing legislation.
Amicus’ team is here to fill the gaps and provide support where you need it most with facility registration, licensing, and permitting services.
We Advise You Every Step of the Way
From helping you respond to an observation or warning letter to helping with documentation for mergers or changes of ownership, we can help with registration, licensing, and permitting in the following areas:
- Response & Remediation
- Pre-Approval Audits (PAIs)
- Regulatory Due Diligence
- FDA ANDA Submission (Generics)
- Pharmacovigilance
Solutions That Meet Your Goals
At Amicus, we have a unique ability to assess and use your business goals and resources to design a realistic, effective, and manageable solution. We have worked with big and small clients and can bridge the gap between large and small budgets to develop client-specific solutions.
We Have a Proven Track Record for Success
We’re Ready to Support Your Organization
If you need help with regulatory affairs, contact us to get started.
