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 […]
Developing Pharmacovigilance Systems in the MENA Region Read More »
With the expansion of clinical research and development, precise labeling of investigational products is not merely a formality but a critical aspect ensuring the safety, efficacy, and regulatory compliance of clinical trials. Pharmaceutical companies are obliged to follow an integrated approach in labeling considering all aspects of clinical study planning to promote multilingual and multicultural
Essential Aspects of Labeling for Clinical Supplies and Investigational Products Read More »
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
Fulfilling stability data requirements for ANADA filings Read More »
Customer Requirement: A pharmaceutical company specializing in generic products, based in Saudi Arabia, required a customized additional risk minimization measure (aRMM) for its generic version of Pomaliomide capsules. This was a requirement of the regulatory agency, the Saudi Food and Drug Authority, in order to maintain safety and regulatory compliance. Problem Statement: The National Pharmacovigilance
Customized aRMM for National PV Center in Saudi Arabia Read More »
Customer Requirement: A USA-based educational institute specializing in providing training courses to its subscribers was looking to develop a course on pharmacovigilance. This course would be the first of its kind for the educational institute and would aim to provide a robust foundational knowledge base of pharmacovigilance, including key activities, processes, and the regulations surrounding
Development of Pharmacovigilance Training Modules for US-based Educational Institute Read More »
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
Drug-device registration in CIS countries Read More »
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
Accelerating access to Women’s Health products Read More »
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
Web-based Lifecycle Management Tool Read More »
The pharmaceutical industry including its operations and associated functions run on data and content. Whether it is safety, regulatory, or clinical data, the pharmaceutical industry and all its stakeholders are actively involved in collecting, monitoring, evaluating, and exchanging crucial information. Indeed, the need for standardization of medicinal product information was highlighted in order to facilitate
Maintaining compliance with Identification of Medicinal Products (IDMP) standards Read More »
The development of biologic products has increased over the last few years in order to treat complex and serious conditions. These biologics, or innovator products, are approaching the end of their exclusivity period which warrants for the development of biosimilars to support timely access to alternative and more affordable treatment options for patients in need.
Biosimilars uptake – An upward trend Read More »
