OUR SERVICES INCLUDE

Registration of Medical Products

We provide regulatory consultancy services for original, generic, biotechnological, biosimilar, and traditional herbal medicinal products in accordance with the current legislation of the Turkish Medicines and Medical Devices Agency (TMMDA).

Preparation of CTD Module 1, 2, 3, 4, 5 and submission of electronic application,
Assistance in responding to deficiencies received during the registration process,
Conducting a GAP analysis and reporting for imported products,
Preparation of a GMP/Registration prioritization file, application, and follow-up,
Preparation of the GMP audit application file for the Production Site, follow-up, and organization of GMP audit processes,
Preparation and follow-up of variations,
Preparation and follow-up of product analysis application files,
Preparation of Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL),
Preparation of primary and secondary packaging artwork,
Generate barcodes,
Assist with pharmaceutical warehouse identification process,
Application and follow-up for sales permit,
Applying for and following up on marketing authorization transfers,
Preparation of marketing authorization renewal file,

Medical Device Registration

We provide regulatory consulting services for medical devices in accordance with the current legislation of the Turkish Medicines and Medical Devices Agency (TMMDA).

Company and product registration procedures,
Class identification,
Follow-up and updating of registered products,
Conformity assessment of documents including declarations of conformity and CE certificates,
Assessment of conformity of labels, written and visual texts with current legal requirements prior to placing on the market,
Preparation of update applications after approval and submission of applications,
Preparation of product catalogues,

Food Supplements

We provide consulting services for the registration of food supplements in accordance with the current legislation of the Ministry of Agriculture and Forestry.

Preparation and follow-up of the permit file,
Registration of manufacturers and importers,
Preparation of applications for approval of imported or manufactured products,
Preparation of control certificate application files for products subject to control certificate,
Preparation and inspection of primer and secondary packaging,
Preparation of GGBS pre-notification and shipment notification applications for post-approval marketing of imported products,
Preparation of the audit file,
Preparation of the application file to the Ministry Commission for the component not included in the Regulation,
Evaluation of compliance of product components prepared for formulation development,
Preparation of application files for post-approval changes to the product,

Pricing

Conducting pricing studies for original, generic, biotechnological, biosimilar, traditional herbal medicinal products according to the current legislation of the Turkish Medicines and Medical Devices Agency (TMMDA) and the competitive situation of the Turkish market and presenting them in the form of a report,
Prepare a price application,

Reimbursement

Determining the reimbursement strategy for original, generic, biotechnological, biosimilar and traditional herbal medicinal products according to the current legislation of the Social Security Institution and the competitive situation in the Turkish market and presenting it in the form of a report,
Preparation and follow-up of the reimbursement application file,

Technology Transfer

Identification of a contract manufacturer for the product for which technology transfer is planned,
GAP analysis and reporting,
Management of technology transfer projects using project management methodology,

Management of Generic R&D Projects

Proposing new product selections that align with the company's portfolio and conducting project feasibility studies,
Providing technical support in developing pharmaceutical forms for national and international markets, adhering to ICH, EMA, and TMMDA guidelines,
Managing R&D projects using a project management methodology,

Hosting Company

Our company provides "hosting company" services for companies and start-ups that are entering the Turkish market for the first time. With the "authorization certificate" provided by the companies, we register products and transfer marketing authorization at any time.

Quality Consulting Services

Building a Quality system according to requirements of cGMP,
Improvement of available quality systems to comply with GMP requirements of EU, FDA, TMMDA,
Consultancy for installation of GMP based production facility (Checking the facility design and clean room design based on GMP requirement, providing solutions to problems based on best practices, etc.),
Quality management system installation according to ISO standards (ISO 9001:2015),
Evaluation and improvement of validation processes,
Establishing a documentation structure in accordance with cGMP and ISO 9001:2015 requirements,
Quality Dossiers and documents review and improvement,
SOP, instruction etc. writing and improvement of the quality of available documents,
GMP Trainings (eg. General GMP trainings, GMP requirements of sterile production, Biotechnological production, validations, quality risk management…),

Quality Audit Services

Auditing domestic and international suppliers (API, excipient, primary packaging, warehouses, service providers, etc.), contracted pharmaceutical production facilities, and contracted laboratories according to GMP and relevant ISO standards,
Performing pre-audit before inspections by relevant health authorities or customers and monitoring of corrective/preventive activities,
Internal audit service; to evaluate company’s compliance level to cGMP and improve company’s current quality system,
Conducting GAP analysis before technology transfer, inspection of the company that will receive the transfer, and preparation of the due diligence report,