Regulatory Affairs
Services

Let our experts handle your registration process — so you can focus on your product.

From CTD dossier preparation to submissions and authority follow-ups, we manage every step with speed, precision, and full regulatory compliance.

✅ Data security and confidentiality are our top priorities
✅ Seamless submissions and complete documentation, handled by our experienced team
✅ Cost-effective, customized solutions to meet your needs
✅ Clear, consistent communication throughout the entire process

We simplify complex licensing procedures and ensure every detail is handled with care — just as we promise: Let us take care.

Dossier Preparation Services

From pharmaceuticals to food supplements, from herbal medicines to biocidal products — we offer complete regulatory dossier preparation for all products that meet relevant eligibility criteria.

✅ Preparation of e-CTD registration dossiers
✅ Development and revision of SmPC (Summary of Product Characteristics) and PIL (Patient Information Leaflet)
✅ Preparation of variation application dossiers
Renewal dossier compilation
✅ Regulatory submissions for traditional herbal medicinal products
Food supplement registration files
✅ Dossiers for biocidal products
✅ Licensing support for veterinary medicinal products

We support you at every step — with compliant, timely, and reliable documentation, tailored to your product.
https://pharmasoft.com.tr/wp-content/uploads/2022/03/Ruhsat-1_1920.jpg
https://pharmasoft.com.tr/wp-content/uploads/2022/03/footer_logo_2.png
https://pharmasoft.com.tr/wp-content/uploads/2022/03/logo_pharma_text-1.png
Demo Request

If you need any information or request a demo about our services and products, please contact us by following this link.

Contact Us

Fetih Mah. Tahralı Sk. Kavakyeli İş Merkezi No:7 A Blok Kat:10 D: 25
Ataşehir/İstanbul/Turkey

+90 216 326 77 12
📠 +90 216 428 39 71
📧 contact@pharmasoft.com.tr

Copyright © 2022 PharmaSoft.com™ | All rights reserved | This website was created by PharmaSoft Development Atelier . Please contact atelier@pharmasoft.com.tr