Regulatory Affairs
Regulatory Affairs Services play a vital role in ensuring the successful development and commercialization of drugs as they navigate the complex and ever-changing landscape of Health Authorities (HA). Ensuring compliance throughout the process is a mandatory requirement. To avoid overlooking procedures across the product life cycle, organizations deploy proven experts for Regulatory Affairs Services and consulting. F2M acts as a crucial link between the organization and HAs, tracking all the key regulations related to the product and prerequisites for its launch.
As a specialized global Regulatory service consulting partner, F2M acts as a bridge between organizations and key Regulatory authorities like the European Medicines Agency and MEB. F2M is a leading Regulatory Affairs Services company and has been a pioneer in providing strategic Regulatory support services. F2M provides comprehensive Regulatory Affairs Services across the spectrum of product development, registration, and commercialization.
F2M’s Regulatory Affairs Services enable pharma companies to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements to successfully launch their products in new markets and maximize their market value.
Our Process
We bring science and innovation together
Regulatory Strategy and Insights
Our strategy insights enable you to confidently navigate the complex Regulatory landscape, ensuring successful product development and approval.
Dossier Authoring
From initial registration to market expansion of the medicinal products,F2M ensures that all Regulatory requirements are met to avoid HA rejections, facilitating successful on-time approvals with all necessary support during HA review and maintaining compliance throughout the product lifecycle by authoring the high-quality dossiers that comply with Regulatory standards and requirements.
Post-Approval/Lifecycle Management
The registered drug products has to remain compliant and competitive throughout their lifecycle. From change control assessment, change submission strategy, preparation, and submission of a variation package to ensure approval receipt from HA, we provide the support needed to navigate the complexities of Regulatory post-approval and lifecycle management.
Artwork maintenance
Up-to-date artwork is essential to inform the patient and communicate with your clients.
