How Complete Compliance Solutions Helps Your Business with Pharmaceutical State Licensing Compliance
Our mission is to provide first-class, personalized state drug and device licensing services to the pharmaceutical supply chain without the big consulting-firm price.
Assessing Licensing Requirements
Navigating the complex patchwork of every state pharmaceutical regulation is complicated and time consuming. There is no single resource detailing drug and device licensing requirements for every pharmaceutical model across every state.
State agencies maintain websites, but pharmaceutical licensing requirements for every pharmaceutical model may not be readily available on the website. So, companies must closely consult state regulations and, in some cases, must contact the state pharmaceutical agency directly with specifics related to their business model to understand their licensing obligations.
We do the work of reviewing state pharmaceutical laws and consulting with state agencies to verify pharmaceutical licensing obligations based on the client's unique business model.
Clients we’ve helped include:
Start-up consumer products and pharmaceutical companies seeking to understand their licensing requirements in order to bring new drug and device products to market
Companies concerned with potential gaps in their existing pharmaceutical state licensing program
Companies involved in corporate transactions such as mergers, acquisitions, and changes of ownership.
Preparing and Submitting Applications
State pharmaceutical licensing application requirements vary by state. Applications are often lengthy and required information can take time to obtain.
Collecting and tracking information is time consuming. Without careful attention and an effective tracking system, applicants risk failing to provide required documentation and delaying receipt of state pharmaceutical licenses.
Once pharmaceutical license applications are submitted, companies must closely monitor each application’s status and promptly respond to state licensing agency communication. As agencies are increasingly short-staffed and face a growing backlog of applications, applicants are encouraged to maintain regular communications with agency staff to stay updated on their drug and device license application status.
Complete Compliance Solutions supports pharmaceutical clients throughout the state drug and device licensing process, from identifying the correct application, collecting and tracking required information, and preparing and submitting the application. Leveraging our closely developed relationship with state pharmaceutical agency personnel, we work quickly to address agency questions and support timely issuance of state pharmaceutical licenses.
Managing License Renewals
State pharmaceutical license expiration dates and renewal processes vary by state. Careful tracking of renewal application requirements and deadlines is critical. Missing a license renewal deadline can result in a costly late fee or a cancelled license.
Complete Compliance Solutions manages our client’s state pharmaceutical license renewals to ensure important renewal deadlines aren't missed. Because license renewal requirements vary by state and often change, we carefully track these details and work with clients to submit pharmaceutical license renewal applications well in advance of expiration to avoid potential licensing disruptions.
Managing Business Changes
When changes to the business occur, state pharmaceutical licensing agencies may require timely notification of these changes. Types of business changes and notification requirements vary by state. Deadlines for change notifications also vary by state with some states requiring notification shortly after the effective change. And, the change notification process can vary from a simple email communication to paper form and a fee.
Complete Compliance Solutions helps pharmaceutical companies manage:
Change of Ownership
Change of Corporate Officers
Change of Designated Representative
Change of Address
Change of Address
When business operations change, we help clients prepare and submit the information required to keep their pharmaceutical licenses compliant.
Monitoring Regulatory Changes
With increased focus on improving pharmaceutical supply chain safety, state licensing agencies are intensifying oversight of OTC and Rx drug and device supply chain partners through amended regulations.
State pharmaceutical licensing agencies often do not maintain effective systems for timely communication of regulatory changes to all stakeholders. And, changes to regulations can be difficult to locate on agency websites.
Complete Compliance Solutions routinely monitors state pharmaceutical licensing agency activities and tracks amended regulations. We communicate when changes to state pharmaceutical regulations impact our client’s regulatory obligations and assist them to maintain compliance.
As a specialized, boutique firm, we work closely with each client to craft an individualized compliance program that's right for their business needs. Our solutions are tailored to meet each client's unique business needs and goals. As a result of our customized, strategic approach, you can spend your time and attention on growing your core business.