Regulatory

It includes a wide range of operations involving assuring compliance with numerous local and international legislation, guidelines, and standards. Regulatory Affairs professionals plan, prepare, and submit regulatory submissions strategically to ensure a smoother path to market access.

To maintain continuous compliance, our regulatory affairs team closely monitors the changes.

Stringent Timeframes

Regulatory submissions always come with the tight deadlines. Within strict timeframes, regulatory affairs specialists swiftly collect, review, and compile.

To overcome the challenges and effectively manage, Regulatory affairs Department of Mazoon Pharmacy, consider these best practices:

Early Engagement

Our Regulatory Affairs team is included early in the ProductMarketing Process. Their insights can help guide decision-making to ensure compliance with regulatory requirements, reducing delays and rework ensuring that the product is launched successfully in the market.Our Regulatory Department also supports the Pharmaceuticals companies in compilation of the lifecycle of eCTD Dossiers.

Continuous Support

The focus of Regulatory Affairs department doesn’t stop with the launch of the product. They also support the Marketing team with Medical enquiries, take care of the Product Quality complaints, Re-calls and Adverse Drug Reaction in alignment with the Pharmacovigilance Department.

Robust Documentation

Documentation is essential to quality and process control. Detailed records of regulatory communications, filings, and compliance efforts are kept. Comprehensive documentation not only helps with audits, but it also helps with future regulatory engagements.

Continuous Learning

Given the ever-changing regulatory context, ongoing learning is critical. To keep up with changing legislation, our regulatory affairs professionals also attend workshops, conferences, and training programs.

Technology Adoption

To expedite regulatory processes and improve decision-making, embrace technological solutions such as Regulatory Information Management (RIM) systems and data analytics