Understanding and complying with regulations is crucial for the success and sustainability of any venture. This article examines key steps and strategies for successfully navigating pharmaceutical regulations.

Gather Regulatory Intelligence

Before launching a new product in any market, conduct thorough research to understand the specific regulations that apply. Gather as much intelligence as possible and track any changes to these regulations. Regulators like the U.S. Food and Drug Administration publish their guidance documents on their websites. You can also utilize other online resources or websites, industry publications, and legal databases to keep updated. It’s also important to connect with industry associations and to get advice from colleagues or mentors who are familiar with those regulations.

Verify the collected regulatory intelligence.

It is vital to verify that published regulations and guidance documents correctly reflect real-world scenarios:

Consult Lawyers or Regulatory Specialists

Consult lawyers who specialize in the pharmaceutical industry. They usually have the knowledge and experience to advise on the practical applications of different regulations. Similar to lawyers, regulatory specialists have the knowledge and experience to interpret regulations and liaise with agencies.

Join Industry Associations and Forums

Networking with industry colleagues can provide information about how regulations are interpreted and executed. Trade associations are usually good forums to table challenges because other members can offer practical advice based on their experiences. 

Attend Regulatory Seminars

Attend workshops and seminars hosted by regulators as these events tend to include case studies and Q&A sessions from which you can learn from.

Build A Regulatory Affairs/Compliance Team

Create a team or hire consultants. This group will be primarily responsible for gathering and updating regulatory intelligence. In most cases, you’d also need legal advisers (to advise on trademarks, intellectual property, and patents), quality assurance, pharmacovigilance specialists, and industry-specific experts. It’s very important to hold regular meetings to review and debate regulatory developments and their potential impact on current and future operations.

Develop a Regulatory Compliance Roadmap

In most cases, compliance with regulatory requirements involves additional financial resources due to agency fees or certain human resource or training requirements. Therefore, having a clear plan can help build compliance over time and avoid costly mistakes. The first step is to outline the various requirements and their potential impacts on your operations. Then, set priorities for critical milestones and deadlines, and finally, develop a system (such as an internal audit) for reviewing and updating your compliance plan regularly.

Engage Regulatory Authorities

Build a positive relationship with regulators. It’s always advisable to have pre-registration meetings with agencies. Some agencies have published guidelines on how to set up these meetings and what resources or documents to bring along. It’s also important to have a company point of contact (a regulatory liaison) with relevant authorities for direct communication with the company. Developing strong relationships can help you stay up to date on developments and potentially influence future regulations or policies.

Develop A Robust Internal Control System

This involves creating internal controls and processes to maintain continuing compliance. For example, frequent training for your team, audits to identify potential issues, and procedures for reporting and responding to compliance concerns quickly.  Most companies will opt for a quality management system such as ISO 9001:2015 (International Organization for Standardization). You can also invest in regulatory technology (RegTech) tools to automate compliance processes. Here are some common RegTech Software.

Veeva Vault QMS

Purpose: Quality management and compliance
Features: Document control, training management, change control, and audit management
Use in Pharma: Helps pharmaceutical companies maintain quality standards and comply with requirements, particularly for Good Manufacturing Practices (GMP) compliance.

IQVIA Safety Cube

Purpose: Pharmacovigilance and drug safety management
Features: Adverse event reporting, signal detection, and risk management
Use in Pharma: Allows for better tracking of adverse effects and helps manage drug safety data to meet regulatory compliance requirements.

Sparta Systems TrackWise Digital

Purpose: Quality management and compliance
Features: CAPA (Corrective and Preventive Action), audits, deviations, and change control
Use in Pharma: Assists with regulatory compliance, ensuring that quality management systems meet FDA, EMA, and other regulatory standards.

ArisGlobal LifeSphere® Regulatory

Purpose: Regulatory information management
Features: Submission planning, regulatory document management, and agency correspondence tracking
Use in Pharma: Streamlines the process of preparing and managing regulatory submissions, which is essential for pharma companies that need to meet various global regulatory requirements.

MasterControl Regulatory Excellence

Purpose: Document and regulatory management
Features: Document control, regulatory submissions, and product lifecycle management
Use in Pharma: Helps manage complex documents required for FDA, EMA, and other global submissions, ensuring regulatory compliance throughout product development and commercialization.

Common Mistakes that Lead to Regulatory Issues

The more compliance issues you have, the lower your rating with authorities. The disadvantage is that it becomes harder to negotiate certain situations with these agencies. In some cases, agencies will provide certain concessions to very compliant companies, especially in areas where regulation is unclear.

  1. Failure to undertake thorough research on the relevant regulations. Being unaware of regulations can lead to unintended violations.
  2. Ignoring local regulations. Regional regulations may vary slightly from federal regulations. In some cases, there might be additional requirements.
  3. Not having a diverse and knowledgeable compliance team.
  4. Neglecting certain aspects of regulations. i.e. some people might focus on financial regulations while neglecting any other applicable regulation.
  5. Failure to adapt to changes in regulations. Regulations can evolve.
  6. Inadequate internal controls. Not having processes for checks and balances.
  7. Poor communication with regulators.
  8. Poor documentation. Being able to prove historical compliances in cases of audits.
  9. Not assessing the impact of regulation on product development or launches.