Regulatory counsel

Looking for A REGULATORY SERVICE?

Regulatory Counsel’s regulatory team is dedicated to providing our clients with the best custom-made regulatory services. We understand the complex and ever-changing regulatory landscape and work closely with our clients to navigate the regulatory requirements efficiently. Here are some of the services we provide:

Regulatory submission

We support our clients in preparing and submitting regulatory dossiers to the relevant regulatory agencies. Our team's extensive experience and profound understanding of the regulatory requirements in Middle Eastern regions position us to provide invaluable assistance in achieving successful submissions for various applications. Our expertise extends across different product classes, including drugs, natural health products, and cosmetics. Helping with the following regulatory process:

Product Classification

Cosmetic product registartion

Medicine product Registartion(NDA, NCA, Generic)

Health Product, OTC & GSL  Registartion

Marketing Authorisation Holder (MAH) Registartion

Manufacturing site registartion

life cycle managment

Variation/ notification with Health Authority

Renewal of the license of the products

Prepare a summary of stability study documents

Coordinating the analysis process with the third-party laboratory

Marketing Authorisation Holder (MAH) Registartion

Regulatory intelligence:

We provide clients with comprehensive, up-to-date insights to support informed decision-making and regulatory compliance. Our key features inlcude timely updates, customised reports, and regulatory guidance. 

 

One- on- One regulatory consultations:

Our consultation sessions are for in-depth discussions, addressing your specific regulatory concerns and providing tailored guidance to overcome regulatory hurdles.

 

Solid daily operation:

Prepare the documents, submit, follow up, and get final approval

 

Provide a training session:

To guide your regulatory affairs team through the registration process in the Middle East. As part of the session, I can offer detailed instructions for each regulatory process within the GCC markets. So your team can work independently.

Labelling review

Regulatory counsel offers a comprehensive labelling review service that ensures accurate and scientific translation and compliance with regulatory requirements. Our expert team, based in Australia and the UAE, specialises in translating English labels into Arabic.


Our labelling review service is designed to meet the specific needs of companies operating in regulated industries such as pharmaceuticals and cosmetics. We understand the importance of clear, scientific, and precise labelling in reaching global markets, complying with local regulations, and effectively communicating product information to customers.     

Translate Middle East regulations and guidlines

Arabic translation for the label and package insert

 Provide regulatory support in developing and/or revising product labeling in accordance with local requirements and in alignment with company policies and standards