Swiss Medic
Swiss Medic
Aquila Solutions is dedicated to supporting pharmaceutical and biologic companies in navigating the complexities of regulatory compliance. Swiss Medic, Switzerland's national authority for the safety and efficacy of drugs and medical products, plays a vital role in regulating these sectors. With its stringent approval processes, Swiss Medic ensures that only safe and effective products reach the Swiss market. We are here to help you align with their standards and streamline your submission processes.
eCTD Regulatory Publishing
Our eCTD Regulatory Publishing service equips you to meet Swiss Medic’s requirements for electronic submissions. We expertly handle the preparation, formatting, and assembly of your regulatory documents in compliance with eCTD specifications. By ensuring accurate and compliant submissions, we facilitate quicker review times and help expedite the approval of your products in Switzerland.
SPL Authoring
Communicating key information about your products is essential for compliance. Our Structured Product Labeling (SPL) Authoring service guarantees that your labeling aligns with Swiss Medic's guidelines. Our skilled team creates clear, standardized labels to effectively inform healthcare professionals and patients about your products, enhancing label accuracy and regulatory acceptance.
Regulatory Consulting
Navigating the intricate Swiss regulations can be challenging. Our Regulatory Consulting services provide tailored guidance and strategic insights throughout the development and submission process. Our consultants stay current with Swiss Medic’s evolving requirements, ensuring that your submissions meet the necessary standards and helping you develop effective strategies for market entry.
eCTD Viewer
Our Altair eCTD Viewer enhances your submission workflow by simplifying document management. As a user-friendly tool, it provides a comprehensive view of your submissions, allowing for easy navigation and annotation. This ensures that your communication with Swiss Medic is efficient and compliant, reducing the chances of delays due to submission errors.
Trust Aquila Solutions for Your Regulatory Requirement Needs
Aquila Solutions stands ready to support your regulatory endeavors with Swiss Medic. Our expertise across various services equips you to meet stringent regulatory standards effectively, ensuring a smoother path for your products in the Swiss market. Connect with us today to learn how we can assist in fulfilling your regulatory needs in Switzerland.