What We Offer
Arkin Consulting Group offers comprehensive FDA and ISO regulatory, quality and clinical consulting services including:
Strategic Regulatory Consulting
Though FDA clearance is not guaranteed ACG has achieved 100% clearance for all submissions when the sponsor provided data.
ACG provides the following regulatory consulting services:
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Strategic Regulatory Consulting & Submissions
- PMA, 510(k), NDA, IND, IDE / HDE Submissions, Amendments, Reporting & Supplements
- Laser Product Radiation Reports
- Establishment Registrations
- Device Listings
- Experienced U.S. Agent
- Negotiations with Government Agencies
- International Dossiers, CE Mark
- US & International Strategic Regulatory Planning
- FDA-483, Warning Letter Replies
- Injunction Strategies
- FDA / ISO Preparation & Attendance
- Internal Auditing
- Crisis Management
- Other Regulatory Consulting