REGULATORY SERVICES


In line with various demands of your company, we act as your own regulatory affairs department and provide support. In this context, we provide agency-based services for market accessing of your products.

Turkish Medicines And Medical Devices Agency Dossier Preparation, Submission And Follow-up Procedures
  • Medicinal Products for Human Use
  • Conventional Herbal Medicinal Products
  • Medical Nutritional Products
  • Sample Analysis
  • Export Regulatory Dossiers
  • Cosmetic Products
  • Medical Devices

  • Turkish Medicines And Medical Devices Agency Dossier
    Preparation, Submission And Follow-up Procedures
    (Click for details)
  • Social Security Institution
    • Preparation, Submission and Follow-up of Reimbursement Dossiers

  • Social Security Institution (Click for details)
  • Turkish Public Health Agency
    • Preparation, Submission and Follow-up of Biocidal Product Submission Dossiers

  • Turkish Public Health Agency (Click for details)
  • Ministry of Food, Agriculture and Livestock
    • Preparation of Food Supplement Submission Dossiers
    • Veterinary Medicinal Products Regulatory Services

  • Ministry of Food, Agriculture and Livestock (Click for details)
  • Consultancy and Follow-up Services

    We provide the following services for Integrated or Modular Regulatory Affairs Consultancy and Follow-up Services for Medicinal Products for Human Use and Traditional Herbal Medicinal Products.

    • Determination of missing/incomplete information or documents of Marketing Authorization (MA) submission dossiers according to TMMDA requirements.
    • Providing technical and logistic support to MA Holders in the supply of missing information and documents
    • Swift translation and preparation of the MA submission dossier in eCTD format in accordance with TMMDA requirements
    • Follow up of the submitted dossier until approval of the preliminary investigation commission
    • Providing technical support to the regulatory affairs department of the companies in the supplying of information and documents requested by TMMDA Regulatory Affairs Commissions
    • Preparation of variation dossiers
    • Preparation of Renewal of Licence dossiers
    • Conducting correspondence with the Ministry
    • Communication with foreign licensers/API suppliers
    • Pursuance of the proceedings in Ankara

  • Consultancy and Follow-up Services (Click for details)
  • Follow-up

    Peforming a follow-up service during the entire regulatory process on demand (replying the commission inquiries – submission for analysis – Pricing, Barcode and Sales permit submissions, etc.)

  • Follow-up (Click for details)
  • CTD Dossiers for Local Products
    • Communication with the manufacturers of Active Substance(s) and Excipient(s) and providing the required documents (DMF, Certificate of Analysis, GMP, etc.)
    • Compiling the manufacturing documents of the drug product in coordination with the contract manufacturer in accordance with the prerequisites of MA submission and legislative requirements,
    • Preparation of 2.4 Non-Clinical Overview – 2.5 Clinical Overview, Summary of Product Characteristics – Package Leaflets and primary and secondary packaging mock-ups.
    • Preparation of the MA Submission Dossier in eCTD format using available data in accordance with current Regulations and Guidelines

  • CTD Dossiers for Local Products (Click for details)
  • Export MA Dossiers
    • Preparation of the required documentation in accordance with the established requirements of the country of export of the drug product.
    • Translation of the required documents
    • If necessary, preparation of 2.4 Non-clinical Overview and 2.5. Clinical Overview Reports.
    • Delivering the run-in dossier in accordance with the regulations of the relevant country

  • Export MA Dossiers (Click for details)
  • Drug Product Sample Analysis Dossier
    • Preparation of the analysis dossier readyto be submitted to TMMDA on demand

  • Drug Product Sample Analysis Dossier (Click for details)
  • Preparation of MA Submission Dossiers for Medicinal Products
    for Human Use, Prescription/Non-prescription Drugs, Conventional
    Herbal Medicinal Products (e-CTD)
  • Type IA, Type IB, Type II Variation Dossiers
    • Determination of missing/incomplete information or documents of your Type IA, Type IB, and Type II variations and changes not included in the scope a variation submission dossiers as per current variation guidelines issued by TMMDA
    • Translation of the required documents
    • Preparation of the variation dossiers in accordance with the TMMDA requirements
    • Submission of e-variation applications on demand

  • Type IA, Type IB, Type II Variation Dossiers (Click for details)
  • Renewal of Marketing Authorization

    Marketing authorization must be renewed before its 5. year from the date of first authorization. Submission dossiers to be prepared for this purpose involve the following steps:

    • Determination of missing/incomplete information or documents Translation of the required documents
    • Preparation of PSURs and Bridge Summary Report dossiers in the desired format and accurate form as per TMMDA requirements
    • Preparation of 2.5 Clinical Overview report

  • Renewal of Marketing Authorization (Click for details)
  • Readabilitiy Test (Patient Information Leaflet)

    The submission of a study protocol in Module 1.3.4 with e-CTD Registration Applications is mandatory. In addition, Readability Test for Medicinal products for Human Use, which the registration process is ongoing, must be submitted prior to the marketing authorization application.
    The purpose of the readability testing is to ensure the arrangement of an easily readable and clearly comprehensible Patient Information Leaflet based on the results of discussions potential target patient groups.
    Studies for Readability Testing will involve the following steps:

      Test Preparation
      • Establishment of the protocol
      • Establishment of the test contents after review of the patient information leaflet
      • Determining target groups and subjects

      Implementation of the Test
      • Control testing with 1 to 2 participants
      • Face-to-face interviews with 10-person groups
      • Mutual interviews with a second 10-person group

      Test Reporting
      • Analysis and assessment
      • Preparation of report and application dossier

  • Readabilitiy Test
    (Patient Information Leaflet)
    (Click for details)
  • Preparation of 2.4 Non-clinical Overview / 2.5 Clinical Overview Reports
    • Literature search for the preparation of 2.4 Non-clinical and 2.5 Clinical Overview Reports Translation of the required documents/texts and preparation of the reports in the specific format as per TMMDA and the Ministry of Health requirements.

  • Preparation of 2.4 Non-clinical Overview /
    2.5 Clinical Overview Reports
    (Click for details)
  • GMP Dossier

    We provide the following services for GMP inspection dossiers for the manufacturing sites of Import Medicinal Products for Human Use in accordance with the current legislation and GMP Guidelines;

    • Preparation of the On-Site GMP Audit Dossiers
    • Preparation of Risk-based Audit Dossiers
    • Preparation of On-File Audit Dossier
    • Communication with the manufacturing company(ies) to be audited and supplying missing/incomplete information or documents on demand
    • Participation to GMP inspection on demand
    • Providing support to the company in the process of responding the deficiencies

  • GMP Dossier (Click for details)
  • Marketing Authorization Transfer

    In cases where companies are planning to purchase licenced products from another company;

    • Informing on the required documents
    • Gathering the required information
    • Compiling the submission dossier in accordance with the TMMDA regulations
    • Follow-up of the process at TMMDA on demand
    • Submission of Price and Marketing License Applications after finalising Marketing Authorization transfer

  • Marketing Authorization Transfer (Click for details)
  • Constitution and revision of SPC/PIL
    • Preparation of Summary of Product Characteristics (SPC) and Patient Information Leaflets (PIL) in accordance with the current guidelines and SOPs of TMMDA
    • Updating the SPC and PIL documents in accordance with the modifications of the originator company
    • Conversion of package insert to the Patient Information Leaflet (PIL) format
    • Preparation of the SPC and PILs by the respective format as per foreign regulations.

  • Constitution and revision of SPC/PIL (Click for details)
  • Preparation of BA/BE Dossiers
    • In the matter of bioavailability and bioequivalence studies for being a prequisite in the drug licencing procedure of particular pharmaceutical forms, preparation of Turkish BA/BE summary reports and in vivo BA/BE and in vitro study dossiers according to the TTMDA format as per current legislation and guidelines.

  • Preparation of BA/BE Dossiers (Click for details)
  • Control Certificate Submissions
    • Preparation of the dossiers to be submitted to TMMDA prior to product importation of the company
    • Electronic submissions
    • Submission of the MoH import declarations on demand

  • Control Certificate Submissions (Click for details)
  • Price Increase / Discount Declarations

  • TITUBB – PTS Company/Document Registrations

  • Preparation of Import Authorization Submission
    for Medical Formulae/Enteral Nutritional Products
  • New Product Pricing Procedure

    New product pricing submissions during the licencing procedure involves the following steps:

    • Reflecting price increases/discounts of the reference product
    • Making amendments in the 20-year status
    • Compiling the required documents, performing the calculations and ensuring the right directions required for the notification of the TMMDA on the price increases/discounts as a result of changes in manufacture/import status.

  • New Product Pricing Procedure (Click for details)
  • Preparation, submission and follow-up of
    biocidal products submission dossiers

    According to the guidelines issued by TTMDA on biocidal products;

    • Identification of product category
    • Preparation of preliminary submission dossier
    • If necessary, ordering the preparation of MSDS of local products for the notified body
    • Preparation of the labels as per guidelines and obtaining approval for the labels
    • Correspondence with laboratories for conducting the analysis
    • Preparation and submission of Technical Documents to TPHI
    • Follow-up of submissions with the TPHI on demand

  • Preparation, submission and follow-up of
    biocidal products submission dossiers
    (Click for details)
  • Global Markets
    • Giving support and guidance on preparation of the dossiers for new application according to the regulation in the region
    • Giving support on the preparation of Type Variation dossiers, Marketing Authorization Transfer dossiers according to the regulation
    • Giving support and consultancy on the regulatory affairs project management and regulatory strategy in different countries
    • Giving support on pricing dossiers in different regions
    • Giving guidance and training to the team on regulatory affairs for different regions
    • Video and audio meetings in order to troubleshoot the issues and planning of the projects in different regions
    • Giving support for PV activities in USA and EU.
    • Following up regulatory procedure of the project with local contacts and giving reports to the team providing a good and strong communication
    • Having meetings with MoH in different regions through local contacts in emerging markets like CIS countries, Balkan countries
    • Finding solutions for the deficiencies and questions asked by the health authorities during the procedure and preparing the response reports for the health authorities
    • Following up the projects on Business Development and giving reports on them
    • Doing the research and GAP analysis about the market and guiding on regulatory compliance of the product according to the regulation in the region
    • Supporting with the contacts and network in required areas for regulatory, PV and marketing activities.
    • Finding niche products for companies, giving the GAP analysis and P&L analysis, informing about the tendency, supporting with contacts.

  • Global Markets (Click for details)