PV Solutions encompasses the reputable Regulatory Affairs team, which comprises of experienced professionals, who provide simplified assistance in the drug approval process for various geographical areas, especially for Europe and the United States.
Active involvement of Regulatory Affairs in the development process of a new medicinal product up to its post-marketing authorisation has ranked the importance of Regulatory Affairs. Our PV Solutions Regulatory Affairs team has been ideally placed to offer you full support service throughout this process.
To protect public health, PV Solutions with its Regulatory Affairs team continuously appraise the quality, safety and efficacy of the drug products. We provide proficient regulatory support for all the areas of pharmaceuticals such as; medical devices, cosmetics and complementary medicines.
PV Solutions team can offer full regulatory support, which includes writing, reviewing and publishing of the dossier for pharmaceutical products, biological products and medical devices. If you are aiming for the marketing authorisation of your product in Europe and the United States, PV Solutions will closely collaborate with your team, and develop a tailor-made regulatory strategy for your product (portfolio) and guide you through the different procedural hurdles and authority interactions.
We support all procedures [National Procedure (NP), Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and Centralised Procedure (CP)] and applications [Investigational New Drug Application (INDA), NDA, Biologics License Application (BLA) and Abbreviated New Drug Application (ANDA)] for the preparation, review, submission (including publishing) and lifecycle management of your Marketing Authorisation Applications. We can also develop and submit dossiers for Commonwealth of Independent States (CIS) countries and Rest of World (ROW) countries for successful registration.
Our team is highly experienced in reviewing the existing dossiers as per the client requirements. Our team includes expert Regulatory Affairs associates and regulatory operations professionals who are experienced and skilled in the preparation, compilation and publication of regulatory submissions. Our team brings together relevant knowledge, skill and expertise to ensure your success with high standards of services. We pride ourselves in maintaining our principles of accuracy, timeliness and responsiveness throughout the entire regulatory lifecycle.
We can support you with the writing and reviewing of: