Regulatory Consulting
C-TASC provides expertise in directly reviewing FDA compliance concerning drug and device products, as well as assistance with product submissions. Additionally, we offer regulatory strategy development and IND, NDA, BLA, and PMA study reports, thus allowing clients to create a marketable product within a set budget.
Our regulatory experts can also review and/or conduct a full audit of your SOPs, internal processes, and software development procedures to ensure HIPAA and 21 CFR 11 compliance.
- FDA Compliance Review
- Product Submission Assistance
- Study Reports
- SOP Review
- Software Development Process Review
- 21 CFR 11 audits
