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Are you a company looking to bring human medicinal products to market? Let Interdos be your reliable partner as a Contract Marketing Authorisation Holder (MAH). With our expertise and experience, we can assist you in obtaining marketing authorisation for your products, while taking care of all communication with competent regulatory authorities.
As a Contract MAH, Interdos offers a unique opportunity for companies to leverage our expertise and resources to navigate the complex regulatory landscape. Here are some key reasons why you should choose us:
Experience and Expertise: Our team of regulatory professionals has extensive experience in dealing with regulatory authorities, and we are well-versed in the requirements and guidelines for obtaining marketing authorisation for human medicinal products. We have a proven track record of successfully obtaining marketing authorisations for various types of medicinal products.
Time and Cost Savings: Outsourcing your marketing authorisation activities to Interdos can save you valuable time and resources. We handle all communication with regulatory authorities, including submission of applications, follow-ups, and compliance, allowing you to focus on your core business activities.
Compliance and Quality Assurance: We are committed to maintaining the highest standards of compliance and quality assurance. Our team ensures that all regulatory activities are carried out in accordance with the relevant regulations and guidelines, minimizing the risk of non-compliance and delays in obtaining marketing authorisation.
Flexibility and Customization: We understand that every company has unique requirements, and we offer flexible and customized solutions to meet your specific needs. Whether you are a small start-up or a large multinational corporation, we can tailor our services to suit your requirements and budget.
Interdos offers a comprehensive range of services as a Contract MAH, including:
Marketing Authorisation Application: We prepare and submit marketing authorisation applications to competent regulatory authorities on your behalf, ensuring compliance with all regulatory requirements.
Regulatory Strategy and Planning: We develop regulatory strategies and plans tailored to your product and target markets, taking into account regulatory requirements, timelines, and risks.
Regulatory Submissions and Compliance: We handle all regulatory submissions, including variations, renewals, and post-approval changes, and ensure compliance with regulatory obligations throughout the product lifecycle.
Regulatory Liaison and Communication: We serve as the primary point of contact for all communication with regulatory authorities, including query management, document reviews, and regulatory meetings.
Pharmacovigilance and Compliance Monitoring: We establish and maintain pharmacovigilance systems, including adverse event reporting, risk management, and compliance monitoring, in compliance with regulatory requirements.
At Interdos, we are committed to providing reliable, efficient, and compliant services as your Contract Marketing Authorisation Holder. With our expertise and experience, we can help you navigate the complex regulatory landscape and obtain marketing authorisation for your human medicinal products.
Contact us today to learn more about our services and how we can support your needs.