Address
304 North Cardinal St.
Dorchester Center, MA 02124
Work Hours
Monday to Friday: 7AM - 7PM
Weekend: 10AM - 5PM
Regulatory Affairs
Ensure the compliance of your products and clinical trials with our expertise in regulatory affairs.
We ensure compliance with local and international regulations.
We offer a comprehensive range of services to meet all your regulatory compliance needs. Each service is designed to ensure that your products and clinical trials adhere to the highest standards.
We prepare and submit regulatory dossiers for new drugs, market authorizations, and post-approval modifications. Our experts ensure that all regulatory requirements are met to facilitate the necessary approvals.
This includes drafting and compiling required documents, coordinating with regulatory authorities, and managing responses to questions and requests for additional information. We also provide regulatory monitoring to stay informed about changes and new requirements that may impact your submissions.
We manage all your regulatory dossiers, ensuring continuous compliance with local and international requirements. Our services include regular updates to the dossiers and preparation for regulatory audits. We maintain comprehensive and up-to-date documentation for all aspects of your products, ensuring that all information is ready for regulatory inspections and audits. Additionally, we conduct periodic reviews to identify and correct potential discrepancies before they become compliance issues.
Our experts provide strategic advice to navigate the complex regulatory landscape. We help develop effective strategies for regulatory submissions and anticipate potential regulatory changes.
Cela inclut l’évaluation des risques et des opportunités réglementaires, l’identification des voies d’approbation les plus appropriées, et la planification des étapes nécessaires pour répondre aux exigences réglementaires tout en optimisant le temps et les ressources. Nous travaillons en étroite collaboration avec vos équipes pour assurer une approche intégrée et cohérente de la conformité réglementaire.
Expertise and Compliance
Our team of regulatory affairs experts has extensive experience and in-depth knowledge of international regulations. We ensure that all documents and processes comply with ICH and local standards, ensuring the
Regulatory Planning
We develop detailed regulatory plans for each project, ensuring smooth execution and continuous compliance throughout the product lifecycle. Our plans include key milestones, deadlines, and clearly defined responsibilities for each phase, ensuring effective and proactive management
Continuous Compliance
We continuously monitor regulations and updates to ensure your products remain compliant. Our experts ensure that any necessary changes are implemented quickly and efficiently. We conduct regular audits and compliance reviews to
Global Coordination
We ensure global coordination of your regulatory activities, including communication with regulatory authorities and management of international submissions. Our team handles interactions with regulators, prepares responses to inquiries, and ensures consistency and compliance across different markets and jurisdictions.
Submission Process and Risk Management
We optimize every step of the regulatory submission process to ensure maximum efficiency and reduced timelines. Our experts ensure that all documents are complete and compliant before submission.
We identify and assess potential regulatory risks, implementing management strategies to minimize negative impacts and ensure compliance.
After submission, we ensure rigorous monitoring and provide regular updates to maintain compliance. We stay in close contact with regulatory authorities to address any questions and provide additional information if needed.
Therapeutic Areas
We operate across numerous therapeutic areas to provide healthcare solutions tailored to diverse needs.
20 Years of Growth and Innovation
For 20 years, Monitoring Force Group has been committed to innovation and continuous development in the field of clinical research. Our subsidiaries, strong partnerships, and diverse expertise enable us to effectively meet the evolving needs of the healthcare products industry.