Quality/Regulatory Consulting
Profarm Medical LLC has a proprietary step-wise modular approach to preparation of regulatory documents. This approach minimizes errors that could result in costly delays while helping our customers fill gaps in their regulatory filing. Focusing on the Medical Device and Diagnostic Industry, we help small companies set up their Quality Systems to be compliant with US FDA and ISO requirements.
- 510(k)
- Medical Device QSR's and SOP's
- ISO 13485 and 14971
- Design History Files
- Internal and External Audits
- IDE
Clinical and Regulatory Writing
Profarm Medical LLC also provides regulatory writing services to the Pharmaceutical and Biotechnology industry to support clinical programs in preparation for regulatory filings including IND's, NDA's and ANDA's.
- Study Protocols
- Investigator Brochures
- Integrated Summaries (Safety and Efficacy)
- Clinical Study Reports
- Patient Narratives
- Briefing Packages
- Annual Reports
- CMC Modules