Regulatory Affairs

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Our Regulatory Affairs ensure your products navigate the regulatory landscape seamlessly from development to market launch. We provide comprehensive, end-to-end services to maintain compliance throughout the product life cycle, including strategy, market access, and post-market surveillance. Committed to excellence, we go beyond basic compliance to be your trusted partner in overcoming regulatory challenges.

Regulatory affairs

Responses to Health Authorities

We handle all interactions with health authorities on your behalf, from responding to queries and requests for additional information to managing the submission of required documentation. Our team ensures that all responses are accurate, timely, and meet the expectations of regulatory bodies.

Product Labelling Maintenance

We help ensure that your product labelling remains compliant with regulatory standards throughout its lifecycle. Our team provides expert support for label design, updates, and regulatory submissions, making sure your product information meets the latest legal and safety requirements.

Approval Lifecycle Management

From initial submission to post-approval, we manage the entire regulatory approval lifecycle. We ensure that all regulatory submissions are complete, compliant, and timely, while navigating complex approval processes to keep your product on track for success.

Regulatory Strategy

We create tailored regulatory strategies that align with your product’s lifecycle, guiding you from preclinical to post-market for optimal approval success. Our regulatory intelligence services keep you informed with the latest global updates, ensuring your strategy stays ahead of changes and minimizes delays or rejections.

Hallmarks of Our Regulatory Affairs

We assist with both global and country-specific regulatory submissions, ensuring your product meets the necessary requirements in each market for a smooth approval process.

We provide comprehensive lifecycle management services, helping you navigate regulatory requirements at every stage, from initial development to post-market monitoring.

Our team specializes in converting NeeS/CTD submissions to eCTD formats using the in-house eXtedo eCTD Manager, streamlining the submission process for regulatory authorities.

We prepare and submit complete CTD, NeeS, and eCTD dossiers, ensuring your submission is accurate, compliant, and ready for review by regulatory bodies.

We offer expert authoring and periodic updates for CCDS, CCSI, USPI, PIL, and SPL documents, ensuring regulatory compliance and consistent messaging across markets.

Hallmarks of Our Regulatory Affairs Solutions

We assist with both global and country-specific regulatory submissions, ensuring your product meets the necessary requirements in each market for a smooth approval process.

We provide comprehensive lifecycle management services, helping you navigate regulatory requirements at every stage, from initial development to post-market monitoring.

Our team specializes in converting NeeS/CTD submissions to eCTD formats using the in-house eXtedo eCTD Manager, streamlining the submission process for regulatory authorities.

We prepare and submit complete CTD, NeeS, and eCTD dossiers, ensuring your submission is accurate, compliant, and ready for review by regulatory bodies.

We offer expert authoring and periodic updates for CCDS, CCSI, USPI, PIL, and SPL documents, ensuring regulatory compliance and consistent messaging across markets.

We manage artwork and associated regulatory documentation, ensuring that all labeling, packaging, and promotional materials meet legal and regulatory standards.

Our regulatory affairs team provides end-to-end support, ensuring your product stays compliant with ever-changing global regulations from development through to market access.

We help you maintain and manage regulatory records in line with industry standards, ensuring secure, accurate documentation and streamlined audits for ongoing compliance.

Talk to Our Experts

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Why Choose Us

Expert Guidance Every Step of the Way

Navigating the regulatory landscape can be overwhelming, but with our expert team by your side, you’ll always have the guidance you need. From strategy to submission and beyond, we ensure that every step is managed with care and expertise.

Focused on Your Success

We treat your goals as our own. Our dedicated approach is focused on helping you achieve market approval and ongoing compliance, ensuring that your product is positioned for success at every stage of its lifecycle.

Adaptable Solutions for Every Challenge

Regulatory affairs is rarely a one-size-fits-all process. We understand that each product and market has its own set of challenges. Our adaptable solutions are designed to meet the unique needs of your product, providing flexibility and support tailored to your specific requirements.

Efficiency without Compromise

We know how important it is to keep things moving in regulatory affairs. Our efficient processes ensure that all submissions are made on time, without compromising on the quality or accuracy of the information, so your product gets to market faster and with fewer hurdles.

Comprehensive Regulatory Network

Our strong relationships with health authorities and industry experts give us an edge in regulatory affairs. With a global network of contacts, we ensure that your product benefits from the latest insights and strategies for regulatory success.