Atvigilx has a profound experience in the filing of Abbreviated New Drug Applications (ANDA). We take our clients through the process step-by-step, ensuring that all regulatory requirements are met and that chances of approval are maximized. Our services include preparation of documents, devising a submission plan, communication with the authorities and making sure your ANDA submission is done in a quick and efficient manner.
At Atvigilx, provision of complete regulatory support service is available to the Marketing Authorization (MA) holder, through which the firm’s pharmaceutical products are kept compliant at all times. Our assignments include all activities related with the MA upkeep such as: out of them are post- approval variation, maintenance and constant change.
Our preparation starts by collecting existing Marketing Authorisation related documents & its compliance status from the Client. This way, we also attempt to mitigate the defects and develop appropriate strategies to compensate those deficiencies.
Our specialists always make sure that there is a record of modifications made and new submissions lodged in compliance with the regulatory requirements. As part of MA services, we particularly manage all regulatory changes and communications with the health authorities. These comprise of: variations, safety amendments and safety reports and reviews periodically.
Atvigilx also offers regulatory strategy & planning, allowing you to understand complexities in regulations and identify possible obstacles. Keeping abreast of industry developments & changes in regulation affecting your products – for compliance & competitiveness.
Atvigilx specializes in Pharmacovigilance, Regulatory Affairs, and GCP Services, providing comprehensive support to ensure compliance…