Regulated industries must ensure compliance with government regulations and laws relevant to their product. PSC Biotech can help you to coordinate with agencies relevant to your company to resolve issues, speed up approvals, set-up and implement standard operating procedures, and handle day-to-day operations. All while providing expert advice on your regulatory strategy. Medical device, healthcare and pharmaceutical industries, in particular, must ensure compliance with government regulations and laws relevant to their product.
Here, PSC Biotech can help you:
- Prepare, review, and assemble document submissions to global regulatory authorities including:
- new applications
- product listings
- investigatory applications
- Coordinate with relevant agencies to resolve issues and speed up approvals.
- Setup and implement regulatory standard operating procedures.
- Handle day-to-day regulatory operations.
- Provide expert advice on regulatory strategy.
The services we provide for Regulatory Affairs include:
- Post Approval Reports
- Biologics License Application (BLA) Submissions
- Regulatory Agency Interaction
- Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs
- Drug Master Files (DMF)
- NDA/ANDA Submissions
If you would like more information, get in contact with us directly here.