Regulatory Consulting

State Licensing Service

Areas of Expertise

Featured Services

Services Overview

DEA Security Requirements
Quality Management Systems (QMS)
Suspicious Order Monitoring (SOMs)
Facility Registration and Drug Listing
FDA/DEA Audit Preparation / Response
21CFR, cGMP and ISO Compliance
Vendor Negotiations and Oversight

VAWD Accreditation and Inspections
Recordkeeping and Reporting
FDA, DEA and State Regulations
Product Recall Management
State Licensing Requirements / PDMA
SOP Development and Compliance
Labeling and Marketing Compliance

We provide certified regulatory knowledge and expertise regarding the laws, regulations, policies and guidelines which affect regulated healthcare products. On a supplemental or retainer basis, we offer reliable, cost-effective guidance and oversight for all the regulatory aspects of your company.

After assisting hundreds of clients acquire and manage their required state licensure, we've developed beneficial relationships with state licensing authorities, allowing our clients to obtain licensure faster and commercialize their products sooner. We offer expert consulatation or complete management of your state licensing portfolio.

We can effectively supplement the regulatory expertise and resources of our clients on an as-needed basis or seamlessly function as their regulatory department, promptly responding to and satisfying all their regulatory needs.