News
Why CMOs and CDMOs Must Prioritize Emerging State Licensing Requirements: A Strategic Imperative
For Contract Manufacturing Organizations (CMOs) and Contract Drug Manufacturing Organizations (CDMOs), the regulatory currents are shifting in ways that directly impact your strategic value and ability to serve sponsors. A growing, and largely under-appreciated, trend...
Puerto Rico Pharma Compliance: Why a Local Representative Agent is Essential
Puerto Rico is a powerhouse for the life sciences industry, offering a strong foundation for pharmaceutical companies. But as many businesses have learned the hard way, operating on the island isn't as simple as it seems. While the opportunities are vast, the...
Why Hand Verification of Trading Partners Outshines Bulk Data Dumps
In pharmaceutical and life sciences supply chains, trust is everything. Every company depends on the accuracy of its trading partners’ credentials to keep product moving, stay compliant, and avoid regulatory setbacks. Yet many organizations still rely on weekly or...
Hold Orders: The Silent Threat to Pharmaceutical Supply Chains
In the pharmaceutical industry, supply chain continuity is everything. Patients rely on uninterrupted access to medication, and companies depend on reliable distribution to meet contractual obligations. Yet lurking beneath the surface is a risk that too often goes...
Third-Party Logistics in Pharma: The Compliance Blind Spot You Can’t Afford to Ignore
Third-party logistics providers (3PLs) are the lifeblood of modern pharmaceutical distribution. They move products, manage storage, and keep supply chains running. Yet too often licensing is treated as a formality, an afterthought to the more visible aspects of...
A Revolution in Medicine, a Maze of Regulations: Virtual Manufacturing in the Pharmaceutical Industry
The pharmaceutical industry is on the cusp of a quiet revolution. No longer is the path from lab bench to patient bedside a linear journey controlled by a single, monolithic company. A new model is emerging: virtual manufacturing. These companies, unburdened by the...
Wholesale Drug Distributor Licensing: What Every Company Needs to Know
Behind every prescription that reaches a patient is a complex and highly regulated supply chain. At the center of it are wholesale drug distributors. These companies do not manufacture or prescribe medications. Instead, they are the logistical experts who make sure...
Why Routine Inspections Matter More Than Ever
Staying Inspection-Ready: How Routine Facility Inspections Keep Your Licenses on TrackAs regulatory expectations continue to evolve, pharmaceutical and medical device companies must stay proactive to maintain uninterrupted operations. One area of increasing scrutiny...
The Uncharted Waters: Navigating States Without Formal Registration and Your Path to Compliance
Beyond the Register: Proactive Compliance in States Without Formal Drug Price Transparency RegistrationsIn our previous posts, we explored the critical role of state drug price transparency registrations, distinguishing between annual and one-time requirements. Today,...