Regulatory Strategies / Expert Views
Regulations pertaining to pharmaceutical products are continuously changing...
Read More ➔The MoH (Ministry of Health), the Government of Morocco, and the ANAM (National Health Insurance Agency) are the prime regulatory organizations accountable for Morocco’s general healthcare admission and rules. The MoH is responsible for designing and executing government guidelines on public health. The Department of Pharmacy of MoH licenses the transaction of new medications in the country based on safety and effectiveness data. Any medication, created locally or imported, even at the example level, must acquire authorization from the Department of Pharmacy, MoH, before deal or allocation (even complimentary). Moreover, this authorization is essential before any medication can be considered for repayment. The MoH declares that a license can only be allocated if the medication meets exact requirements for proper testing to emphasize effectiveness, guarantee its safeness under standard prerequisites, confirm its medicinal value, and demonstrate bioequivalence for a generic drug.
As a leading global contender, DDReg’s Regulatory Services in Morocco provides on-going support and development of 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 filing 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 ➔