Understanding and following medical regulations is crucial if you want to bring new products to market or keep existing ones compliant. Regulatory Review helps you:
Avoid legal issues: By ensuring all product materials meet current regulations.
Speed up market entry: By making the approval process smoother with preemptive compliance checks.
Reduce risks: By identifying and addressing potential regulatory obstacles early in the product lifecycle.
Our careful scrutiny and expert insights protect your investments and help your product succeed in the competitive medical marketplace.
Ensure that your product's labels and packaging not only meet regulatory standards but also effectively communicate critical information to consumers and healthcare professionals.
From clinical trial protocols to marketing materials, our experts scrutinize every document to certify compliance with the latest regulatory mandates.
We assist in preparing and reviewing all necessary documentation for regulatory submissions, helping to streamline the approval process and reduce delays.
Identify and mitigate potential regulatory risks throughout the product lifecycle, ensuring continuous compliance and safeguarding against potential market withdrawals or legal challenges.
Monitor your product’s performance in the market, ensuring ongoing compliance with regulatory requirements and adapting quickly to any needed changes.
Recognizing that each client has unique needs, we offer customizable service packages tailored to your specific product and market objectives. Whether you’re launching a new product or managing an existing one, our flexible approach ensures optimal support for your regulatory needs.
Our regulatory review process is comprehensive yet straightforward, ensuring clarity and efficiency from start to finish. Here’s how we work with you to achieve compliance:
Start with a free consultation to discuss your product and understand your specific regulatory needs. During this phase, we gather all necessary documentation and information to tailor our approach.
Submit your product’s labels, packaging, and supporting documentation through our secure client portal. Our team will review all materials to ensure completeness before the evaluation begins.
Our experts conduct a thorough review of all materials against the latest regulatory standards and guidelines. We identify any areas of non-compliance and provide detailed feedback for necessary changes.
We deliver a comprehensive report outlining our findings and suggestions for compliance. You can then make the required revisions or, if preferred, work directly with our team to amend the materials.
After revisions are made, we conduct a final review to ensure all changes adhere to regulatory requirements. Once confirmed, your materials are ready for submission or distribution.
Post-review, we offer ongoing support to keep your products compliant with any new regulations and to assist with any additional regulatory needs that arise.
Background
A biotech company was preparing to launch a Phase III clinical trial for a promising new cancer drug. The trial was set to run in 16 countries, including the United States, Germany, Japan, China, and more. Each of these markets has strict and different regulatory requirements for the labeling of Investigational Medicinal Products.
Challenge
The main challenge was ensuring the IMP labeling complied with the diverse and complex regulations of each country. Non-compliance could delay the trial, lead to penalties, or invalidate the study results, impacting the drug's market launch and success.
Objective
We aimed to conduct a comprehensive regulatory review of the proposed IMP labels to ensure full compliance with FDA, EMA, and PMDA regulations, facilitating a smooth and timely start to the global clinical trial.
Process
Regulatory Strategy Development: Our team collaborated with the client to understand the specific requirements of the clinical trial and developed a tailored regulatory strategy for IMP labeling.
Document Review and Compliance Assessment: We conducted a detailed review of the initial label drafts, comparing them against the latest regulatory guidelines issued by the FDA, EMA, and PMDA. All subject matter expertises joined this project are manager-level with 7+ year experiences on both regulatory guidelines and translation.
Label Revision and Localization: Based on our findings, we provided specific recommendations for changes to the wording, layout, and language translation requirements. We ensured that each label met local regulations while maintaining consistency across different regions.
Final Review and Approval: After implementing the revisions, we performed a final compliance check before the labels were printed and applied to the IMPs.
Outcome
Compliance Achieved: All IMP labels were approved by the respective regulatory bodies with no additional modifications required.
On-Time Trial Launch: The clinical trial commenced on schedule in all regions, avoiding costly delays.
Risk Mitigation: Potential legal and financial risks associated with non-compliance were successfully mitigated.
Conclusion
This case demonstrates the critical role of expert regulatory review in launching international clinical trials successfully. By ensuring the IMP labels complied with all regional regulations, the biotech company could move forward confidently, knowing their product met every legal requirement for a successful study.
Our regulatory review services offer significant advantages to ensure your medical products not only comply with stringent regulations but also excel in the marketplace. Here’s what you can expect:
We help speed up the approval process, allowing you to launch your products faster in new and existing markets by ensuring compliance with all regulatory requirements.
Our expert review minimizes the risk of regulatory pushback, fines, and costly delays. Avoid the pitfalls of non-compliance with proactive evaluations.
Products that consistently meet regulatory standards gain greater trust from consumers and healthcare professionals, enhancing your brand’s reputation.
Our services aim to prevent unexpected expenses associated with regulatory rejections and product recalls. By investing in thorough regulatory reviews, you save on potential future costs.
Gain valuable insights into regulatory trends and updates. Our team provides strategic advice that helps you navigate complex regulatory landscapes effectively.
We understand that each product and market is unique. Our services are customizable to meet the specific demands of your products and the regulatory requirements of your target markets.
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