Maximize Regulatory Affairs Efficiency
The Regulatory affairs play a pivotal and ever-expanding strategic role in the success of brands and companies. Our Regulatory team helps organizations to navigate through increasingly complex systems. Companies realize the need to balance heavier workloads and to narrow the margin for submission errors; therefore always on the look for of the best and most effective way to get things done correctly and on timely manner.
Top-performing companies are outsourcing their regulatory affaires in order to gain maximum efficiency and prevent the wasted time and to optimize regulatory affairs performance.
Our Regulatory affairs department has never been more vital to companies’ health. We deliver to our partners the service of professionals skilled in the regulatory process. Our team insures that our partners follow the best-recommended practices for overcoming the toughest challenges in the current regulatory environment.
Below are the main services that can be provided by our team:
- Providing the most updated regulations and circulars related to drug, medical devices and food supplement registration.
- Regulatory intelligence information regarding practical processes and procedures related to drug, medical devices and food supplement registration.
- Defining regulatory strategy and assessing registration feasibility.
- Reviewing the available dossier and identifying the parts to be updated to comply with local regulations (gap analysis).
- Full assistance in the preparation of Module 1 documents including packaging and labeling requirements.
- Price assessment based on the local regulations.
- Reviewing the full marketing authorization application before submission.
Improve Submission Timelines
As regulatory affairs becomes more dynamic, success boils down to the correct dossier submission and gaining approval. Our team helps companies identify and overcome hurdles in your regulatory processes to get products to market as soon as possible.
Manage the Impact of registration in different MENA countries
When companies plan to register in more than one of the MENA countries, the regulatory team will be dealing with the hurdle of different regulatory requirements. Harmonization of regulatory requirements and working things in bundles, implementing the correct processes and applying best practices will help companies stay on top of changing rules and regulations and reduce lost times, wasted money on unnecessary paper work and legalizations; preventing the negative impacts that may result from the many loopholes.