Regulatory Strategies / Expert Views
Regulations pertaining to pharmaceutical products are continuously changing...
Read More ➔The Jordan Food and Drug Administration (JFDA) was established in 2003 by the Ministry of Health (MoH) to ensure safety, efficacy, quality and compliance of food and medicinal products according to national authority guidelines and working committees such as the Food Law and Drug and Pharmacy Law. The Drug Directorate of the JFDA is responsible for meticulous monitoring of drugs from early pre-marketing to post-marketing surveillance stages. It also oversees the Importing and Exporting, and Monitoring and Inspection departments for the approval and safe use of all medicinal products, devices, Pharmacovigilance Services, and biologics. Additionally, the JFDA includes the Clinical Studies, Information, Pricing, and Rational Drug Use departments that supervise and follow up on important aspects of drug monitoring. However, due to regular changes in legislations and regulations surrounding medicinal products the timeframe for marketing authorization can be prolonged. Therefore, it is important for manufacturers to be well-informed and constantly updated of such changes.
As a leading global contender, DDReg’s regulatory services in Jordan provides on-going support and development of the customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.
Regulations pertaining to pharmaceutical products are continuously changing...
Read More ➔Pharmaceuticals and other medicinal products need to be prior authorized by...
Read More ➔A gap analysis is a regulatory review process that identifies data gaps in the technical...
Read More ➔Regulatory issues arise unexpectedly and can create significant strain on a company’s...
Read More ➔DDReg provides expert consulting and efficient services for quality Drug Substance...
Read More ➔When it comes to regulatory strategies, CMC documentation play a crucial role in developing...
Read More ➔Managing the post-approval life cycle of a product is an essential component to sustaining...
Read More ➔Administrative documents are an integral component of regulatory submissions and constitute key certifications...
Read More ➔The regulatory approval pathway for Abbreviated New Drug Applications (ANDAs) is relatively complex....
Read More ➔