PHELIXMED PHARMACEUTICALS CONSULTANCY LLC

PHELIXMED is a Regulatory Affairs Consultancy company for pharmaceuticals, medical devices, cosmetics, supplements, biocidals and food for special purposes (FSMPs).

The regulatory affairs function is vital to launch high quality, safe&effective products available for patient access.

We are passionate to work with you to be the success partner of your regulatory procedures in Turkish market.

PHELIXMED,

- provides full range of regulatory services covering all stages of the product life cycle; all the regulatory affairs work to receive and maintain a registration approval.

- has broad experience for regulatory pathways of pharmaceuticals, biopharmaceuticals, biologicals and vaccines.

- provides support along the GMP certification procedure, including accompanying on-site inspection on behalf of you when needed.

- provides market access services covering strategic support for pricing&reimbursement submissions.

- provides support to register your medical device/cosmetics/food supplement/ biocidal/FSMP product.

- provides support for the governmental affairs relations and follow-up procedures in Ankara where the Turkish health authority is based.

- provides Patient Leaflet Readability testing service

- provides timely and high quality translation services with our translators who have a good command of the pharma terminology.

- evaluates braille texts on mock-ups and provides expert letter on braille conformity check.

-QR multimedia code - audio patient leaflet for visually impaired patients.

Our dedicated expertise at PHELIXMED will contribute and add value throughout the process. We take the time to understand each client’s unique business objectives and operations to successfully solve problems, avoid risk and accomplish tasks correctly the first time in a genuine way.

If you have any further questions about our consultancy services or would like to find out more about working with us, please get in touch via info@phelixmed.com or visit phelixmed.com.