360 Degrees
Consulting
Services
Consulting
Services
ASA provides services in the fields of registration,
market access, price and reimbursement, auditing,
quality, training and translation services.
market access, price and reimbursement, auditing,
quality, training and translation services.
Registration
Registration Consultancy
- To provide the necessary support to customers who plan to operate in Turkey’s market for thOe first time.
- Realization of correspondence and negotiations on behalf of the company with global and local authorities.
- Performing a GAP analysis to determine the deficiencies and risks before the application.
- For consultants to companies; operational execution of all registration activities with the support of staff in their offices.
2 Registration Services
- Detection of the deficiencies of the dossier in accordance with the regulations (GAP analysis)
- Preparation of license application files in e-CTD format
- Preparation of Type I and II variation reference files to ensure product lifecycle
- Converting NTA format files to CTD format
- Preparation of license renewal application dossier
- Preparation of quality, clinical / non-clinical summary
- Preparation of license transfer applications
- Joint marketing application and process monitoring
- Preparation and updating of Short Product Information and Packaging Leaflet in accordance with SPC / PIL / CCDC / circular / announcements and reference SPC/PIL.
- Preparation of Application forms for Bioavailability and Bioequivalence
- Realization of readability test (preparation of readability test protocol and questions) and reporting (creation of voice record and statistical data of the participants)
- Specialist control and approval of the suitability of Braille (embossed) text in the product packaging for Turkish translation.
- Responding to the DLs received from the Agency and making an electronic application.
Preparation of GMP Dossier and GMP Audit
- Pre-Audit Before Authority Audit
- Deficiency detection and risk analysis of documents that should be included in the GMP application dossier (GAP analysis)
- Preparation of GMP on-site audit applications and actively providing on-site support to GMP audit, if requested
- Preparation of risk-based GMP audit applications
- Preparation of dossier based GMP audit applications
- Necessary correspondence with the Authority until the GMP certification process
Medical Device
- Preparation of necessary documents for TITUB (Turkey Medicines and Medical Devices Institution) registration of the company
- Determination of application documents according to the medical device class
- Registration of UBB Product and / or Document
- Follow up of registered products
Biocidal
- Filling the pre-application form (Annex 9)
- Preparation of biocidal product dossier
- Submission of biocidal product license transfer applications
- Document renewal applications for registered biocidal products
- Making applications for biocidal product changes
- Providing additional information if requested by Public Health and TITCK.
Supplementary Food Permit Applications
- Authorization application dossier preparation / follow-up services
- GGBS import product / shipment notification
- Approval applications
Veterinary Drug Registration Services
- Preparation of the Veterinary Medical Product License Dossier in e-application format
- Updating existing registered products according to the new regulation
- Preparation of Part III and Part IV of the Registration Dossier
- Preparation of variation dossier (Type IA, Type IB and Type II)
- Summary of Product Specifications, package insert and preparation of inner and outer packaging
- Marketing permission renewal application
- Sales permit application
Kozmetik
- Performing Safety Assessment for Cosmetic Products and preparation of product information dossier
- Registration of cosmetic product
- Supporting the preparation of instructions for use, labels and packaging and checking their suitability
- Cosmetic product inspection and analysis applications
Follow-up with Authorities
- Supporting with Corporate Relations
- Following the stages of applications to Turkish Medicines and Medical Devices Agency, Social Security Institution, Ministry of Food, Agriculture and Livestock, Public Health Laboratory, TOBB and, to direct the department about the application processes and developments by ensuring a continuous flow of information to the Regulatory Affairs Department.
- Providing and directing the questions about the official procedures of the institutions in Ankara of other departments within the company and the documents required to be answered.
- Apostille procedures are carried out for all necessary certificates and documents through the Ministry of Foreign Affairs, Foreign Consulates and the district governorship / governorship
- To ensure that all applications made by the Foreign Trade, Marketing and Regulatory Affairs Departments on behalf of the company are delivered in accordance with the procedure, to be received and forwarded to the company.
Price and Reimbursement
- Preparation and application of price application dossier in line with current guidelines and regulations
- Preparation and application of reimbursement dossier in accordance with current guidelines and regulations
Translation Services
- Written translation services
- Notarized translation services
Quality
GMP based Facility Building Consultancy
Quality Management System Establishment, Certification
Quality Management System Consultancy
Operation Control and Follow-up Methods
GMP Audits and
Assessments
Pre-Certification
Audit
Document and Design
Control
Creating and Developing
SOP
External management of quality management systems and associated processes
Training
General
Registration
Training
Registration
Training
Training of Summary of product characteristics (spc) and package insert.
General GMP
training
training
In addition, in line with the needs of our clients, Quality-based trainings such as Deviation Management, Complaint Management, Supplier Qualification, Root Cause Evaluation are provided.
