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State Compliance Services
When it comes to compliance, not every company needs the same thing. That is why we have different service packages, to fit every size and type of business. Let our expert professionals analyze your portfolio and handle all your compliance needs. If you are just starting out, we’ll perform an in-depth analysis of company development and timelines for worry-free launches. From determining which resident state is the most advantageous to every license requirement based on exact business model, products, customers and vendors, we have all of your bases covered!
Initial Assessment and On-going Compliance
Basic Process Support
- Provide access to the state assessment for your specific business model
Full Process Management
- Determine licensing requirements (with type) based on a company’s unique business model, products, customers and vendors;
- Analysis for determining the most advantageous resident state (as applicable);
- Analysis of company development and timelines for worry-free product launches (manufacturers).
Obtaining New Licenses
Basic Process Support
Expert support for your team.
- A comprehensive on-boarding process that provides detailed information on what is needed to successfully complete each State application;
- Digitally complete required applications with submission letters and detailed instructions on how to assemble and submit your application;
- Client support portal to upload all application documents and issued permits.
Full Process Management
Complete outsourced management.
- Everything in Basic Support;
- Dedicated account manager that provides a project update bi-weekly phone call and email;
- Access to a client support portal for:
- Full transparency on state-by-state progress;
- Secure repository for application documents and issued permits;
- Ensure application materials are up to state requirements and standards;
- Work with state agencies as the application contact to expedite the licensing process and follow up on any deficiencies/issues with the application;
- Business registrations and foreign entity filings where required;
- Fingerprint registration and submission;
- Introduction to required third-party contracts (e.g. surety bond, etc.).
Renewals
Basic Process Support
Expert support for your team
- A comprehensive on-boarding process that provides detailed information on what is needed to successfully complete each State application;
- Provide quarterly updates with a general compliance review by providing new licensing / regulation;
- Renewal reminders according to the unique requirements of each state;
- Client support portal to upload all application documents and issued permits.
Full Process Management
Complete outsourced management.
- Everything in Basic Support;
- Dedicated account manager that provides a project update bi-weekly phone call and email;
- Access to a client support portal for:
- Full transparency on state-by-state progress;
- Secure repository for application documents and issued permits;
- Ensure application materials are up to state requirements and standards;
- Work with state agencies as the application contact to expedite the licensing process and follow up on any deficiencies/issues with the application;
- Business registrations and foreign entity filings where required;
- Comprehensive quarterly compliance review to ensure compliance with Federal and State requirements.
Examples of Business Models Served
- Pharmaceutical Manufacturers
- Wholesalers
- 3PLs
Highlights
- Immediate information on trends
- Updates on best practices
- 1000+ licenses obtained
- 15+ business models served
Frequently Asked Questions
Q: Does my company have to be registered as a business entity in every state into which pharmaceutical products are distributed?
A: Business entity registration requirements vary between states. The following states require business entity registrations to conduct business within the state (Five Rivers RX can obtain business entity registrations on behalf of clients):
- Alabama
- Alaska
- California
- District of Columbia
- Florida
- Illinois (if doing business under an assumed name)
- Maine
- Missouri
- Montana
- New Jersey
- North Dakota
- Texas
- Utah
- Vermont
- Virginia
Q: What is a registered agent? How do I obtain one?
A: A registered agent is a third-party individual, located in a state in which a business entity was established, who is designated to receive correspondence from legal and governmental authorities in that state on behalf of a company. The following states require registered agents to conduct business within the state (Five Rivers RX can obtain registered agents on behalf of clients):
- Alaska
- California
- District of Columbia
- Florida
- Maine
- Missouri
- Montana
- New Jersey
- New York
- Pennsylvania
- South Dakota
- Texas
- Virginia
- Maryland
Q: What are the minimum requirements my facility needs to meet in order to pass an inspection and conduct business?
A: Facility requirements vary based on the company’s state of residence and business model. Ask Five Rivers RX about scheduling a mock inspection to ensure that all facility requirements are adequately addressed prior to your facility’s inspection!
Q: What (if any) SOP’s and facility requirements must be met for Virtual Manufacturers?
A: While Virtual Manufacturers do not physically handle product themselves, there are still specific SOP’s that must be developed, maintained, and followed to ensure compliance to that jurisdiction’s pharmaceutical regulations. These SOP’s include important details for the operations of a Virtual Manufacturer, such as record maintenance, recall protocol, and alarm/security system description, for example.
Q: What is the National Association of Boards of Pharmacy’s (NABP) Drug Distributor Accreditation? Is this accreditation required for obtaining licensure in any states or jurisdictions?
A: The NABP’s DDA accreditation is available to facilities engaged in the wholesale distribution of pharmaceutical drugs and devices. Among other necessities, his accreditation requires a rigorous review of the applicant’s standard operating procedures and a thorough screening through the NABP Clearinghouse. Ultimately, the DDA helps to prevent contaminated, diverted, or counterfeited product from inappropriately entering the pharmaceutical supply chain. While NABP DDA accreditation is not needed for obtaining all licensure, it remains a specific requirement for several states or jurisdictions.
Q: Which businesses must be registered with the FDA and/or DEA?
A: Any company that physically manufactures products or labels products with its own likeness must be registered with the FDA. Any company that is manufacturing, handing, and/or distributing controlled substances of any schedule must obtain a DEA registration.