Regulatory

Customer Requirement: A biopharmaceutical company aimed to submit 19 biosimilar applications across various emerging and Rest of the World (ROW) markets within a short timeframe. The company required a regulatory strategy that addressed potential gaps, identified the most efficient submission pathways, and aligned with diverse regulatory expectations to ensure successful and timely approvals. Problem Statement […]

Customer Requirement: A regional regulatory authority in the MENA region sought to address critical gaps in their pharmacovigilance (PV) systems to enhance drug safety monitoring for a portfolio of their products, across the region. The key objectives of the PV system were as follows: Establishing robust PV systems in underdeveloped regions Aligning PV standards with

Customer Requirement: An animal product company, based in Ireland, wanted to file an abbreviated new animal drug application (ANADA) with the United States Food and Drug administration (US FDA) for its non-steroidal anti-inflammatory drug (NSAID) product. The drug is used to relieve pain and inflammation that is associated with osteoarthritis & control post-operative pain in

Customer Requirement: A global Non-profit organization in the area of female health & wellness wanted to obtain drug device registration and market authorization for their contraceptive that included its administration device, in CIS region, including Azerbaijan, Kyrgyzstan and Tajikistan.  The contraceptive was classified as a drug-device combination product for which regulations are challenging to navigate

Customer Requirement: Women’s health and fertility are vital aspects of their overall well-being, and yet they often remain shrouded in silence and misconception. Every woman has the right to access healthcare, irrespective of their socioeconomic background or geographical location, though many women face significant challenges and barriers that restricts their access to the medications they

Customer Requirement: A Non-profit organization faced challenges in tracking and monitoring the registration status of their products in respective regions. This is because they had one product  in multiple markets that were each in different stages of their lifecycle. Siloed and disconnected tracking systems meant that the organization was left with little insight into the