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Why leading pharmaceutical companies rely on GAN Integrity

GAN Integrity is how compliance teams at pharmaceutical companies get the tools and expertise to stay ahead of risk. With less effort and more reach, you finally get a better way to do your good work. 

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See everything – Gain a comprehensive view of overall risk and compliance in one centralized platform for more effective program management.

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Adapt to anything – Leverage dynamic workflows and integrations to stay ahead of regulatory changes and evolving program requirements, all without heavy lifting or expense.

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Get all the help you need – Receive dedicated support from GAN Integrity’s team of experts.

Compliance challenges for the pharmaceutical industry

Compliance officer challenge

As a compliance professional in the pharmaceuticals industry, it can feel like you're up against an unfair fight. You face a myriad of regulations from agencies such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and laws like the Health Insurance Portability and Accountability Act (HIPAA). Key areas of focus include drug safety, data privacy, and supply chain transparency.  New regulations, such as the German Supply Chain Act (LKsG) and the Corporate Sustainability Due Diligence Directive (CSDDD or CS3D), extend compliance obligations to include third parties and suppliers.

You must ensure your organization builds a strong ethical culture and acts with integrity in all business dealings. This involves implementing robust compliance policies and training programs, managing conflicts of interest, gifts, and disclosures—especially in interactions with pharmacies, healthcare providers, and government entities.

Key areas of compliance in pharmaceuticals

Pharmaceutical companies are complex enterprises. There are many areas of compliance, ethics, and risk that need to be managed, spanning everything from Environmental, Social and Governance (ESG), to Data Protection to Anti-Bribery And Corruption (ABAC). These include:

  • ABAC Compliance: Upholding anti-bribery and anti-corruption (ABAC) laws such as the Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act.
  • Drug Safety and Quality: Ensuring all products meet safety and quality standards in compliance with regulations like FDA and EMA.
  • Clinical Trials Compliance: Ensuring adherence to regulations governing clinical trials, including patient consent and data privacy.
  • Data Protection: Safeguarding sensitive information and ensuring compliance with data privacy regulations such as HIPAA.
  • Supply Chain Transparency: Ensuring suppliers and partners comply with relevant laws and standards and maintaining visibility into the entire supply chain.
  • Ethical Sourcing: Implementing ethical practices in sourcing and production to meet consumer and regulatory expectations.
  • Regulatory Submissions and Reporting: Complying with regulatory submissions and reporting requirements for product approvals.
  • Environmental Compliance: Minimizing the environmental impact of operations.
  • Labor Laws: Observing fair employment practices and labor standards.
  • Intellectual Property Protection: Protecting patents, trademarks, and copyrights.

Steps to achieving compliance in the pharmaceutical industry

Achieving compliance in any organization involves a series of strategic steps:

Compliance in the Pharmaceutical Industry

1
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Risk Assessment

Identify potential compliance risks specific to your pharmaceutical operations.

2
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Objective Setting

Define clear compliance goals that align with your operational objectives.

3
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Documentation

Maintain thorough records of compliance efforts and decisions.

4
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Training

Educate employees about compliance requirements tailored to the pharmaceutical industry.

5
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Monitoring and Auditing

Regularly review compliance status and adjust practices as needed.

6
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Reporting System

Establish clear channels for reporting issues and disclosures.

7
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Issue Response

Quickly address non-compliance issues to prevent disruptions.

8
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Continuous Improvement

Regularly update compliance practices to stay ahead of regulatory changes.


GAN Integrity for Pharmaceutical Companies

GAN Integrity helps pharmaceutical companies navigate these challenges with a unified, easy-to-use compliance platform that organizes requirements, automates tasks, and provides powerful reporting, making it easier for you to do your good work. With GAN Integrity, compliance teams can see everything, adapt to anything, and get all the help they need.

ABAC Program Management

Ensure your organization upholds ethical integrity and ABAC compliance through comprehensive risk assessments, effective policy management, and continuous monitoring. Capabilities include:

  • Third-party due diligence: Mitigate bribery and corruption risks with integrated questionnaires, sanctions checks, and risk intelligence data.
  • Disclosure management: Consolidate and assess conflicts of interest, gifts, travel, entertainment, and political and charitable contribution disclosures.
  • Reporting and documentation: Maintain a complete audit trail and detailed reporting to easily demonstrate compliance to stakeholders and regulators.
GAN Integrity ABAC Compliance

The GAN Integrity Platform means all your compliance and ethics programs can be managed in one place - now that's better.

Frequently Asked Questions

What is the role of a pharmaceutical compliance specialist?
A pharmaceutical compliance specialist plays a crucial role in ensuring that pharmaceutical companies adhere to a myriad of regulations from agencies such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and laws like the Health Insurance Portability and Accountability Act (HIPAA). Their responsibilities encompass developing and implementing robust compliance policies, managing key areas such as drug safety, data privacy, supply chain transparency, and anti-bribery and corruption (ABAC) compliance, while also fostering a strong ethical culture within the organization.
Pharmaceutical regulatory compliance refers to the adherence of pharmaceutical companies to laws, regulations, and guidelines set by governing bodies to ensure the safety, efficacy, and quality of drugs and medical products. It encompasses a wide range of activities, including drug development, clinical trials, manufacturing processes, quality control, labeling, marketing practices, and post-market surveillance, all aimed at protecting public health and maintaining the integrity of the pharmaceutical industry.
Compliance in the pharmaceutical industry refers to the adherence to a myriad of regulations and standards set by agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), covering areas like drug safety, data privacy, and supply chain transparency. It involves implementing robust compliance policies, training programs, and managing various aspects of business operations to ensure ethical conduct and integrity in all dealings, particularly in interactions with healthcare providers, pharmacies, and government entities.
The compliance department in the pharmaceutical industry plays a crucial role in ensuring that companies adhere to complex regulatory requirements and ethical standards throughout their operations. This department is responsible for developing and implementing policies and procedures to prevent violations of laws and regulations, conducting internal audits, providing training to employees on compliance matters, and managing relationships with regulatory agencies to maintain the company's integrity and legal standing.
Pharmaceutical compliance refers to the adherence of pharmaceutical companies to laws, regulations, and industry standards governing the development, manufacturing, and distribution of drugs and medical products. It encompasses a wide range of activities, including following Good Manufacturing Practices (GMP), maintaining data integrity, ensuring product safety and efficacy, and implementing robust quality control systems to meet the stringent requirements set by regulatory bodies such as the FDA and EMA.

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