How to Select the Right Regulatory Writing Company for Your Organization's Needs
In a landscape defined by ever-evolving global guidelines from health authorities, many life sciences organizations’ clinical and regulatory teams face challenges in navigating the regulatory affairs writing and document submission process. Adhering to strict rules while balancing the concerns of multiple stakeholders, timelines, and costs can be a profoundly complex undertaking in this high-stakes environment.
To successfully expand their products globally and launch life-saving medications safely, regulatory teams must have writing support. Let’s examine the top five considerations when selecting the right regulatory writing and consulting company to fit your organizational needs.
Expertise and Experience
Attention to detail, effective communication of scientific data, and copywriting skills are paramount, of course, for any regulatory and medical writer. Beyond the basics, however, consider companies with regulatory writers who have an extensive understanding of life sciences industry regulations and guidelines, with experience submitting documentation across health authorities. They should be knowledgeable on utilizing document authoring tools for specialized templates, single-sourcing publishing, and CCMS systems that support content reuse—all ideal for conforming to regulatory standards.
To see a potential partner’s expertise in action and analyze its track record, check its website and social media channels for client testimonials and case studies. As an added benefit, look for regulatory writers with advanced scientific degrees and certifications that enhance their credibility in the field, such as a Regulatory Affairs Certification (RAC) for their region, American Writers Association (AMWA) certification, Drug Information Association (DIA) certificate, or European Medical Writers Association (EMWA) certificate.
Quality Assurance
The importance of ensuring high-quality regulatory writing submissions cannot be emphasized enough. Regulatory authorities require error-free and accurate documentation, with the risk of approval delays and legal penalties if completed incorrectly. Look for skilled regulatory writing companies that utilize document management systems to ensure compliance, validation, and version control.
While reviewing a company’s website and social media channels, inspect its certifications for quality management systems, such as the ISO 9001 certification. To further assess the quality of work, securely request writing samples of previous regulatory documentation that you need the most support with, such as complex clinical study reports, protocols, and investigator brochures.
Flexibility and Customizations
For effective regulatory teamwork, finding a regulatory and medical writing company open to various collaboration methods is critical. Since research projects and regulations evolve and change rapidly, regulatory writers need to be flexible in adapting their writing to new data and information without compromising on quality and compliance. For operational efficiencies, the right regulatory writing company will be able to customize its offerings to the organization’s needs and scale resources when necessary.
Technology and Tools
The latest advances in generative artificial intelligence (GenAI) and machine translation technologies have revolutionized the regulatory content creation and submission process. Regulatory affairs teams are constantly inundated with administrative tasks, and global guidelines require regulatory content submissions to be translated into local languages for clinical trials.
The right regulatory writing company’s GenAI and machine translation services can automate the extraction, analysis, synthesis, and translation of large text volumes. Generative AI-powered writing assistants support historically manual tasks, such as drafting and reviewing regulatory documents for grammar, style, and compliance. This process does not replace the medical writer, since the human should be kept in the loop to verify the quality and accuracy of the AI’s outputs.
Cost-Effectiveness and Value
Every life sciences organization, from growing start-ups to top 10 pharmaceutical companies, has its own unique scope dependent on its resources and project timelines.
In order to find a regulatory writing company that meets their needs, regulatory teams should request detailed quotes from multiple companies to analyze the full picture of their service offerings. Full-service companies can even eliminate the need for additional vendors, saving money down the line, whereas add-on services can support organizations with smaller budgets or less complex projects. With the right regulatory writing company, there is inherent value in the company’s expertise, reliability, and efficiency, leading to reduced costs and faster timelines.
Conclusion
By partnering with a regulatory writing company with industry expertise, robust quality assurance systems, flexibility and customization capability, cutting-edge GenAI and MT technology, and cost efficiencies, regulatory teams can easily navigate the complexities within the content submission process.
Interested in partnering with an expert regulatory and medical writing solutions team to create regulated content for patients, HCPs, regulatory approvals, and more? TransPerfect Life Sciences’ medical writers deliver 100% compliant documents while reducing timelines by over 30% and expenses by 25% on average. Reach out to our team today.