What are Regulatory Affairs and how to choose the service provider?
Regulatory requirements play a crucial role in every stage of pharmaceutical product development and are established and overseen by Regulatory Agencies, governmental bodies operating at national or supranational levels. The Regulatory Affairs department ensures strict adherence to these requirements, responsible for securing approval for new products and maintaining it throughout their market presence. Its primary aim is to liaise with Regulatory Agencies, balancing regulatory compliance with the agency’s responsiveness to consumer needs.
Selecting a competent and qualified Regulatory Affairs service provider is paramount for effective product development. Our team of professionals offers comprehensive and tailored support to meet each client’s specific needs, ensuring drug safety and efficacy.
Our expertise in regulatory affairs consulting dates back to 1988, under a different company name. Our objective is to devise a regulatory activity plan aligned with client requirements and regulatory standards, leveraging the support of an international team of experts (Regulatory Intelligence network).
Our pre-authorization Regulatory Affairs service ensures comprehensive and effective development of pharmaceutical products from the stages of marketing authorization request. The professionals working in the Regulatory Affairs department stay updated on current legislation, guidelines, and other regulatory information concerning drug development processes, ensuring their proper adherence. This work requires coordination with various teams collaborating in different stages of product development and ongoing dialogue with Regulatory Agencies of different countries to discuss issues related to guideline deviations, clinical study programs, or formulation creation. Our team of professionals ensures full support until the attainment of Marketing Authorization (MA), guaranteeing efficient and precise process management.
VI.REL Pharma offers a comprehensive post-authorization Regulatory Affairs service, ensuring continuous compliance with evolving legislation and guidelines. Following authorization, pharmaceutical products require ongoing monitoring due to regulatory updates and emerging information impacting product characteristics. The Regulatory Affairs department not only ensures adherence to current regulations but also acts as a liaison with Regulatory Agencies to discuss and propose legislative changes. Our team of specialists guarantees prompt notification to Regulatory Agencies regarding any updates, changes, or renewal requests for Marketing Authorization (MA).
Engaging with Regulatory Agencies is crucial to foster a dialogue that strikes a balance between current laws and regulations and the needs of industries and consumers. VI.REL Pharma’s highly skilled and experienced team excels at strategically interacting with both national and European Regulatory Agencies to enhance product value and streamline update processes throughout every stage of development.
At any stage of pharmaceutical development, seeking scientific advice from Regulatory Authorities on optimal methods and study designs is essential to gather reliable safety and efficacy data, minimizing the risk of significant objections during the marketing authorization evaluation process. VI.REL Pharma offers comprehensive support for requesting Scientific Advice from both national and supranational Regulatory Authorities. With our team’s extensive experience, we ensure proper and effective interaction with Regulatory Authorities, providing clear feedback to our clients.
Orphan Drug Designation
Orphan drugs are employed for diagnosing, preventing, and treating rare diseases. In Europe, a condition is deemed rare if it affects no more than 5 individuals per 10,000 inhabitants. To secure orphan drug designation in the European Union, a medicinal product must meet specific criteria, with designation requests evaluated by the Committee for Orphan Medicinal Products (COMP). VI.REL Pharma delivers comprehensive consultancy throughout all documentation drafting phases, collaborating with Regulatory Authorities to ensure accurate request management.