Professionals Regulatory Affairs, (PRA) is a GCC Healthcare regulatory affairs consultancy, based in Dubai, UAE.
PRA is a leading consultancy company formed in 2013 to provide best practice and standards in the Healthcare sector. It provides regulatory and technical support to health care providers and Companies in the region in sectors such as Pharmaceuticals, herbal, medical devices, homeopathy, FMCG, supplements, cosmetics and personal care products.
Our firm is an active member in Dubai Chamber of Commerce.
PRA is a preferred partner helping clients to access and penetrate the market legally with a highly experienced team of pharmaceutical regulatory affairs experts. We can work with clients remotely or onsite, and are supported by a resourceful and hardworking back office making sure you achieve your goals.
Having such a team of talented and dynamic individuals enables us to bring in the appropriate resources tailored to your needs and organization, adding value to your company starting from day one.
PRA is involved in a wide variety of activities related to healthcare regulatory affairs health such as consultancy, education and events management. We cover the GCC region and Jordan.
PRA as a consultancy, assist clients in guiding their product registration in line with the country specific requirements, document compilation for submission, responding to the queries of the authorities and finally obtaining the approval or registration of the product all under one roof.
In our daily work and interactions with clients, agencies and colleagues, we apply the following values
Quality – we maintain the highest professional standards. We adhere to scientific and regulatory principles. Quality starts with the qualifications and competence of our consultants, and is further assured and shaped by our professional approach, our focused way of working, and continuous improvement.
Dedication – we are committed to meet project deadlines and client expectations. Workload is monitored so that projects are handled in a dedicated and expedited way.
Integrity – integrity is the corner stone of our organization and company culture. It is mirrored by the strict confidentiality and the ethical conduct that we apply throughout our services.
Respect – we respect your values, opinions, and decisions; we respect you as true partners.
Thoughtfulness – in our aspiration for perfection, we do not just carry out what needs to be done. We carefully reflect upon the impact of strategies before actually implementing them.
“We are always satisfied working with professional regulatory affairs. They are well organized, and put a lot of efforts to perfect their work . They are very cooperative, and give extra care for solving issues and dealing with changing situations.”
Sawsan Mohammed, Supervisor of Health Educators, Abbott Nutrition
“PRA is one of the dynamic & vivid organizations that we worked with. Our relationship has strengthened to the level of partnership.
From the early beginning more than 4 years ago only because of their dedication; commitment & practicality. We at Cosmedical Solutions Consider PRA as one of the best regulatory firms within the GCC ; add to this that they are the first that come to mind when a consultation or a referral in the pharma business is in need.”
Dr. Amr Ismail, Pharma Manager, Cosmedical solution
“PRA is a super professional company that had helped our company on many levels, their team is equipped and gave us the necessary genuine advise when it came to Ministry of Health, Country regulation and the best way to enter into the market. Their Knowledge, Experience and Network had proven to be solid and utmost beneficial and a service that comes with care and prompt delivery keeping a transparent update at all times. Thank you PRA Team.”
Ayesha Kouwatly, Nspire4
“PRA is really professional, the name is self-explanatory…..
They are one of the few business partners who willingly shares their vast knowledge in regulatory affairs in UAE, I can always count on them to give me the most relevant updated information and advice on any regulatory topic, they are always up to date, and provide service with high quality, speed and exceptional level of follow up,,,, they are a true partners”
Lama Aljada Operation and commercial manager, Celsius
“We have been dealing with PRA team for almost 1 year now. Such a cooperative and knowledgeable one, which creates Gateway for the most updated registration regulations in UAE and GCC. We appreciate the professionalism of PRA team”
“I have been working with PRA for over a year now on my various brands registration here in the UAE. I have found PRA to be a very professional and efficient company to work with for product registration. Their dedicated team are very helpful and knowledgeable when it comes to the complex registration system ere in the UAE.
They have saved me countless hours and made registration for my brands in CPRE and also in food safety very easy and straight forward. Dr Mona and her team provide very detailed feedback and are great at communicating with the DM and the principal company.
I would not hesitate to recommend PRA to anyone who is looking to register a product here in the UAE. They are certainly the best company for the job.”
Andrew Powell, Sports nutrition, The Principals Mena
“PRA is a group of fantastic professionals. We have been dealing with them for more than one year now. They fight for your goals in this difficult regulatory world and never give up until they get what it is demanded. It is not worth to lose time in regulations when you can rely on a profesional company which is highly specialized and efficient.”
Hugo Domínguez, General Manager, Pinnacle EMEA
“The stupendous service, technical knowledge of the regulatory requirements, follow up and feedback of queries are handled in a very meticulous and precise fashion with immediate response.”
“If you are looking to introduce medical products to the UAE market, PRA is the agency to have in your corner. They have a smart, hard-working and flexible experts. Dr Mona, will help you for the registration, and will give you unbelievable advices, as she has an unrivalled knowledge of the UAE Market. Afterward, Dr Najiba can help you and assist you from A to Z, to organize your events, and promote your products. She has a large database of UAE KOLs. I would highly recommend PRA to any company looking for an agency to quickly and efficiently tackle their brand development.”
Mr Imad Khalfi, Managing Director of ReduStim, UAE
“Lunatus Marketing & Consulting is a UAE based company that has established a successful track record in introducing, building and developing profitable brands in the fields of Pharmaceuticals, OTC, Aesthetic Medicine, Skin Care, Consumer Health and Medical Devices. We are very pleased with our experience with Professional Regulatory Affairs and their professional team.”