Regulatory Responses
Regulatory responses and communications involve responding to safety requests from regulatory authorities and communicating important and urgent safety information identified by the marketing authorization holder to regulatory authorities.
Regulatory Request for Information Response Management
At Qinecsa, we understand that responding effectively to regulatory authorities’ request for information (RFIs) is critical to maintaining compliance and ensuring continued access for your products. Our services provide comprehensive support for addressing health authority inquiries regarding safety concerns, signal evaluations, and risk management activities.
Our team of scientists and medical professionals are here to support and develop strategic, scientifically sound responses to regulatory queries. We analyse the underlying concerns, evaluate available data, and craft detailed responses that address the authorities’ questions while maintaining a balanced perspective on your product’s benefit-risk profile.
Expedited Requests and Document Preparation
We recognise that many regulatory inquiries come with tight deadlines that require prompt action. Our dedicated team specialises in managing expedited responses, implementing efficient processes that ensure timely submission without compromising on quality or accuracy.
Our services include the preparation of all necessary documentation, such as response letters, supporting analyses, updated risk management plans, and supplementary data summaries. We also ensure all materials are formatted according to regulatory specifications.
After documents are submitted, our support extends to include the management of follow-up questions. We analyse client and regulatory feedback, and adapt future communication strategies based on accepted responses. Ultimately, this creates a continuous improvement cycle for regulatory interactions.
Navigating complex regulatory landscapes with regulatory responses and communications ensuring compliance and strategic responses pertaining to benefit-risk profile of therapies.
Regulatory Communications
Qinecsa supports our clients in the preparation and submission of comprehensive regulatory communications such as emerging safety concerns, aggregate reports, updated risk management plans, and updated labelling documents.
Regulatory Responses
Our team of expert scientists and physicians support evaluation of additional safety data such as broader ICSR data and medical literature to respond to regulatory requests pertaining to new safety concerns.
Importance
Regulatory responses and communications are key when handling drug safety to ensure potential health risks in which a therapy could pose to patients are identified and thus acted upon in a timely manner.
Working with Qinecsa for Your Needs
Partnering with Qinecsa for regulatory RFI management provides you with access to a team that has in-depth regulatory knowledge with practical experience in handling complex safety inquiries. Together, we can approach each project with a thorough understanding of your specific needs, and customise our services to align with your product portfolio and organisational requirements.
