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Regulatory Affairs Services

Scope of Regulatory Affairs Services

With PharmaSoft's expertise, we ensure that the regulatory affairs processes for pharmaceuticals and medical products are managed in full compliance with national and international legislation. All operational processes, including application file preparation, communication with authorities, follow-up, and updates, are carried out systematically and completely.

By closely monitoring the current requirements of the Turkish Medicines and Medical Devices Agency (TİTCK) and relevant regulatory authorities, we ensure the rapid and safe market entry of products. This aims to minimize time losses in the processes, completely eliminate legal compliance risks, and increase process efficiency.

Our Regulatory Affairs Advantages

Full Compliance with Legislation

All application preparations must be carried out in accordance with TİTCK legislation and international regulations

Fast Market Entry

Effective process planning and proactive authority monitoring minimize time losses, enabling rapid market entry for medical products

Complete Dossier Management

Ensuring that all application and license files are prepared and managed accurately, completely, and kept up-to-date at all times

Professional Authority Communication

All official correspondence, notifications, and process follow-up with relevant health authorities are conducted entirely within a professional framework

Regulatory Affairs Service
Regulatory Affairs Quality Steps

Dossier Preparation Services

We offer comprehensive file preparation services, led by expert staff, for all product groups meeting authority compliance criteria, including pharmaceuticals, dietary supplements, traditional herbal products, and biocides. These end-to-end operational processes include the following steps:
  • e-CTD Filing: Preparation of license application files in e-CTD format in accordance with current legislation
  • SPC and Instructions for Use (IFU) Management: Preparation of SPC and IFU texts in accordance with relevant legislation and guidelines and completion of necessary revision steps
  • Variation Applications: Professional creation of official application files for changes (variations) in licensed products
  • License Renewal Files: Timely and complete compilation of license renewal files to maintain the validity of expired licenses
  • Herbal Medicinal Product Applications: Management of specific license application processes required by legal regulations for traditional herbal medicinal products
  • Food Supplement Files: Preparation of technical and administrative application files required for the approval stages of food supplements
  • Biocidal Product Regulatory Affairs: Creation of specific application files for the registration and regulatory affairs approval steps of biocidal products
  • Veterinary Medicinal Products: Conducting the regulatory affairs processes of veterinary medicinal products in accordance with relevant legislation and legal requirements
Regulatory Affairs | PharmaSoft