Puerto Rico DOH has opened virtual orders for virtual manufacturers & distributors
Are you aware?
13 states have important upcoming licensing deadlines between November & December
Are you aware?
4 states have released news on their drug price transparency requirements in 2024
Are you aware?
In 2024, several states have passed drug takeback programs, new 340B requirements, and more
Professional Services
Our state regulatory experts advise and support organizations in the pharmaceutical supply chain to understand and comply with a patchwork of ever-changing state regulations and requirements.
State Licensing Mangement
Full oversight of your entire licensing portfolio, including:
Submission of renewals of all existing licenses
Submission of new license application to state boards
Point of contact with state agencies to expedite the licensing process
Process and submit all of your business’ change applications to state boards
Assessments & Custom Research
We will perform thorough research and provide a complete state compliance requirement assessment unique to your business model, product portfolio, and customer base
Initial licensing assessments
Single-state licensing assessments
Change Of assessments
NABP Drug Distributor Accreditation
We help you get awarded NABP Drug Distributor Accreditation with a roadmap to success:
Application preparation and submission
SOP standards review of NABP requirements
Supply Chain Inspection Preparation
Mock Audit based on NABP surveyor questions
Inspection preparation through a gap analysis to identify and address deficiencies
Post-inspection assistance with refining any process or documentation
Pharmacy Accreditations
Support with LegitScript and Healthcare Merchant Accreditation
NABP Supply Chain Inspection preparation
Policy and Procedure Development
Puerto Rico Services
State licensing
Controlled substance licensing
Representative Agent
Product Registration for prescription and over-the-counter (OTC) products, active pharmaceutcial ingredient (API) devices, and controlled substances