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Why leading life sciences companies rely on GAN Integrity

GAN Integrity is how compliance teams at life sciences 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 regulatory risk and compliance in one centralized platform.

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Adapt to anything – Leverage dynamic workflows and integrations to stay ahead of regulatory changes and evolving program requirements.

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

Compliance challenges for the life sciences industry

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As a compliance professional in life sciences, it can feel like you’re facing an unfair fight. You must navigate a complex web of regulations from entities like the FDA, Therapeutic Goods Administration, and European Medicines Agency. New regulations, such as the German Supply Chain Act (LKsG) and the Corporate Sustainability Due Diligence Directive (CSDDD), extend your obligations to third parties and suppliers.

Your responsibilities cover product safety, clinical trials, data privacy, and managing compliance across extensive supply chains. Ensuring a strong ethical culture and acting with integrity in all business dealings is crucial. This involves implementing robust compliance policies and training programs, managing conflicts of interest, gifts, entertainment, and disclosures with pharmacies, healthcare providers, and government entities.

Key areas of compliance in life sciences

Life Science 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 Good Manufacturing Practices (GMP) and Anti-Bribery And Corruption (ABAC). These include:

  • Supply Chain Due Diligence: Ensuring suppliers and partners comply with relevant laws and standards.
  • Product Safety and Quality: Maintaining high standards for product safety and quality, including compliance with Good Manufacturing Practices (GMP).
  • Transparency in payments: Recording monetary payments or other “transfers of value” (conference travel, speaking engagements, consulting assignments, etc) and reporting these annually in compliance with the Sunshine Act. 
  • ABAC Compliance: Upholding anti-bribery and anti-corruption laws and standards.
  • Data Protection: Safeguarding sensitive information in an increasingly digital landscape and ensuring compliance with data privacy regulations, including HIPAA and GDPR.
  • Pharmacovigilance: Ensuring the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
  • Environmental Compliance: Minimizing the environmental impact of operations.

Steps to achieving compliance in the life sciences industry

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

Compliance in the Life Sciences Industry

1
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Risk Assessment

Identify potential compliance risks specific to your life sciences 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 life sciences 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 Life Sciences Companies

Our life sciences compliance software helps 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.

Disclosure Management

Consolidate your disclosures for conflicts of interest, gifts, travel, entertainment, and political and charitable donations or contributions. Capabilities include:

  • Policy management: Develop and enforce comprehensive disclosure policies. Educate and engage your workforce with targeted training and policy attestations.
  • Flexible disclosure process: Simplify the submission of potential conflicts of interest with user-friendly forms, ensuring easy access for employees.
  • Automated approvals and reviews: Enhance compliance with automated approval and review workflows. Quickly escalate notifications to relevant stakeholders to address potential risks.
GAN Integrity Disclosure Management

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


In our comprehensive compliance guide for the life sciences industry we cover major trends, regulatory developments, and challenges facing the industry today. We explore simple best practices that companies can adopt to address these challenges effectively.

What’s inside?

  • Trends in life sciences and their compliance implications
  • Key areas of compliance in the life sciences industry
  • Compliance best practices in life sciences

Frequently Asked Questions

What is life sciences compliance?
Life sciences compliance refers to the complex set of regulatory requirements and ethical standards that companies in the pharmaceutical, biotechnology, and medical device industries must adhere to in their operations. It encompasses a wide range of areas including product safety, clinical trials, data privacy, supply chain management, anti-bribery and corruption measures, and environmental regulations, all aimed at ensuring the integrity, safety, and ethical conduct of life sciences organizations.
Life sciences companies are regulated by a complex network of governmental bodies, including the FDA (Food and Drug Administration), Therapeutic Goods Administration, and European Medicines Agency. These regulatory agencies oversee various aspects of the industry, from product safety and clinical trials to data privacy and supply chain management, ensuring that companies maintain high standards of compliance and ethical conduct in their operations.
Regulatory affairs in life sciences encompass the complex web of regulations and compliance requirements that companies must navigate to ensure the safety, efficacy, and quality of their products. This field involves managing compliance across various areas, including product safety, clinical trials, data privacy, supply chain due diligence, and adherence to standards set by regulatory bodies such as the FDA, Therapeutic Goods Administration, and European Medicines Agency.
Compliance in biotech encompasses adherence to an array of regulations and standards set by various regulatory bodies, including the FDA, Therapeutic Goods Administration, and European Medicines Agency. It covers a wide range of areas such as product safety, clinical trials, data privacy, supply chain management, and ethical business practices, all aimed at ensuring the integrity, safety, and efficacy of biotechnology products and processes.

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