Partnering for Compliance: What Platforms and Pharmaceutical Manufacturers Need to Know

What Is Pharmaceutical Manufacturing?

Pharmaceutical manufacturing refers to the industrial-scale production of drugs for human or veterinary use. Companies in this space vary widely, from large, brand-name pharmaceutical firms focused on research and development, to manufacturers producing generic alternatives to branded medications, to contract manufacturers that make products on behalf of other companies.

Because of the risks that drugs pose to consumers, pharmaceutical manufacturing is highly regulated. In the United States alone, regulatory bodies that oversee aspects of the industry include the Food and Drug Administration (FDA), the Drug Enforcement Agency (DEA), and the Federal Trade Commission (FTC), as well as state regulators. LegitScript Certification helps confirm that pharmaceutical manufacturers are operating in compliance with the laws in all jurisdictions where a company operates and serves. 

How Pharmaceutical Manufacturing Is Changing

Pharmaceutical manufacturing is big business. The global industry is expected to grow from $540 billion in 2025 to $1.12 trillion in 2030. One reason for this immense growth is the rise of direct-to-consumer services driven by online pharmaceutical marketing and the growing number of telehealth companies. This shift aligns with evolving consumer expectations for more accessible, digitally integrated healthcare delivery — a trend accelerated by the pandemic and fueled by rapid advancements in health technology.

A more direct relationship between manufacturers and consumers can provide immediate benefits for consumers, such as reduced costs, ease of access, and increased choice. However, due to public safety concerns, regulators are placing heightened scrutiny on the online promotion, distribution, and payment processing for pharmaceutical manufacturers, especially those engaging in direct-to-consumer (DTC) models or partnering with telehealth platforms and fulfillment pharmacies.

Because of this regulatory scrutiny, online advertising platforms such as search engines, social media companies, and streaming services are more carefully vetting manufacturers who want to advertise on their platforms. Likewise, payment companies are increasingly seeking new methods to validate the compliance of pharmaceutical manufacturers — particularly those operating under a DTC model.

Where We See Risk in Pharmaceutical Manufacturing — and How to Stay Ahead

Navigating healthcare regulations is inherently complex, and even well-intentioned pharmaceutical manufacturers can encounter unexpected compliance challenges. Based on our experience supporting pharmaceutical companies, here are several key areas where compliance issues most frequently emerge — and where proactive attention can make a meaningful difference: 

Unvetted Partners of Virtual Manufacturers

Virtual pharmaceutical companies are those who outsource production of their product, which is beneficial for new or smaller companies that lack the resources to perform some services in-house. While the virtual manufacturer may present as compliant, it’s also important to take a closer look at their contracted partners. These relationships can unintentionally introduce risks — like labeling issues, unapproved ingredients, or gaps in quality control — that might not be immediately visible but could have regulatory consequences.

How we help: LegitScript verifies both the applying merchant and any contracted partner performing outsourced manufacturing to ensure continued compliance across all operations.

Past Disciplinary Action

It’s important to have a full view of a company’s history of operations. Regulatory bodies like the FDA, DEA, FTC, and the European Medicines Agency (EMA) routinely monitor manufacturers for violations such as failures in good manufacturing practices (GMP), misleading advertising, and product misbranding. Overlooking a pharmaceutical manufacturer’s disciplinary history before allowing them to advertise or process payments can expose platforms to serious compliance risks — including regulatory enforcement actions, reputational damage, financial penalties, and potential liability for enabling the promotion of unsafe or noncompliant products.

How we help: LegitScript evaluates adverse legal, disciplinary, or regulatory actions, as well as any fines or reprimands related to financial transactions pertaining to the applicant within the past 10 years.

Direct-to-Consumer Advertising by Manufacturers

Direct-to-consumer (DTC) advertising is currently operating in a complex and evolving regulatory environment, making it difficult for advertisers to consistently interpret what compliance looks like in practice. Some manufacturers may launch campaigns before establishing a fully compliant supply chain – including proper labeling, substantiated product claims and appropriate disclosures. These gaps can create significant risk for both platforms and patients, such as the promotion of unapproved drugs, misleading health claims, and violations of FDA and FTC regulations. For platforms, this can lead to regulatory scrutiny, enforcement actions, reputational harm, and potential liability for facilitating the sale of noncompliant or unsafe products.

How we help: LegitScript closely monitors relevant regulatory updates and guidance, including those related to direct-to-consumer advertising. We translate this information to actionable insights and proactively inform certified clients of changes that may affect their certification status. As part of the certification process, pharmaceutical manufacturers must demonstrate compliance with applicable advertising, labeling, and product standards. This not only helps advertisers navigate a fast-moving and often ambiguous regulatory landscape, but also gives platforms the confidence to support high-risk industries while reducing their exposure to regulatory scrutiny and reputational risk.

Inspection Reports

Reviewing inspection reports is essential to ensure pharmaceutical manufacturers comply with safety, quality, and regulatory standards. Failing to evaluate these reports can result in platforms promoting noncompliant or unsafe products such as contaminated medicine, misleading labeling, or failure to meet safety standards. 

How we help: LegitScript verifies that manufacturers have passed inspections within the last five years, confirming their adherence to good manufacturing practices, quality control procedures, accurate product labeling, and established safety protocols. 

Problematic Affiliations/Links

Pharmaceutical manufacturers often promote or link to other businesses on their domain, typically through common ownership or partnerships. If these connections aren’t verified, platforms risk enabling consumers access to unverified, potentially noncompliant, or illegal operations. 

How we help: LegitScript evaluates all affiliates, commonly owned domains, partners, and links to in-scope business models associated with the applying domain to ensure they meet compliance standards.

Problematic Products or Marketing

It’s crucial to review the products a manufacturer promotes to ensure they have FDA-approved labels and aren’t marketed for off-label use. Promoting unapproved claims or off-label uses can pose health risks, and potentially mislead consumers. Noncompliance can lead to FDA warning letters, fines, or legal actions.

How we help: LegitScript verifies manufacturers do not promote unapproved claims, misrepresent data, or overstate drug benefits. We verify that prescribing info, side effect warnings, and accurate claims are included to prevent false advertising and regulatory violations, protecting consumers and platforms.

LegitScript Helps to Identify Compliance Issues and Opens Up Advertising Opportunities for Pharmaceutical Manufacturers

As pharmaceutical manufacturers grow and expand their reach, maintaining a seamless, reliable relationship with online advertising and payment platforms becomes increasingly important. A key part to this relationship is the ability to demonstrate ongoing compliance and a clear commitment to best practices.

For Pharmaceutical Manufacturers: Why Get Certified

LegitScript Healthcare Merchant Certification is a trusted way to build credibility and demonstrate your business complies with applicable laws and regulations. It can also open the door to valuable opportunities for growth:

• Healthcare Merchant Certification is an important step for gaining access to advertising on major platforms, including Google, Meta, Netflix, TikTok, Microsoft, Yahoo, LinkedIn, and NextDoor.
• Certification streamlines the process of obtaining and maintaining a merchant account. Card networks such as Visa and Mastercard recognize LegitScript Certification as part of their MCC 5122 and 5912 high-risk merchant registration process. 
  • Additionally, many acquirers and payment processors recognize – or require – Certification when onboarding new merchant accounts. 
• Certification can help prevent costly disruptions. Early alignment with future platform expectations can keep your business running before mandates are enforced.