Atvigilx excels in expert preparation & submission of Abbreviated New Drug Applications (ANDA). We offer meticulous guidance throughout the process, ensuring compliance with regulatory requirements & maximizing approval success. Our team handles documentation preparation, submission strategy development, & regulatory interaction, ensuring your ANDA submission is streamlined & effective.
At Atvigilx, we provide comprehensive regulatory support for Marketing Authorization (MA) holders, ensuring your pharmaceutical products maintain compliance throughout their lifecycle. Our services encompass all aspects of MA maintenance, including post-approval changes, renewals, and ongoing regulatory submissions.
Our approach begins with a thorough review of your existing MA documentation & compliance status. We identify any gaps or areas for improvement & develop tailored strategies to address these issues effectively.
Our expert team ensures that all changes & updates are meticulously documented & submitted in accordance with regulatory requirements. Throughout the MA lifecycle, we offer continuous support to manage regulatory submissions & interactions with health authorities. This includes handling variations, safety updates, & periodic safety reports.
Atvigilx also provides strategic advice on regulatory strategy & planning, helping you navigate complex regulatory landscapes and anticipate potential challenges. Staying current with industry trends & regulatory changes for your products’ compliance & competitiveness.
Atvigilx specializes in Pharmacovigilance, Regulatory Affairs, and GCP Services, providing comprehensive support to ensure compliance…