Market Access

• Preparation of:

-Pharmaceutical/medical device reimbursement submission files

-Pharmacoeconomics: analysis and modeling

-Alternative reimbursement models and submission files

-Scientific reports and presentations

• Project management and follow-up of Market Access activities

• Network map management; building and coordinating an ecosystem of the project, including:

 –  Pharmaceutical Industry

 – Medical Devices & Technologies 

– Payers

-Governmental Institutions

– Specialty Associations

-Policy Makers

-Delivery Systems & Hospitals

-Physicians

– Patient Organizations 

• Market analysis for pharmaceuticals and medical devices

• Market Access feasibility reports in pharmaceuticals, medical devices, and healthcare

• Establishment and coordination of advisory boards; expert panels

• Medical support to marketing activities

• Healthcare Investment and pharmaceutical production consultancy 

Regulatory Affairs

• Preparation and follow-up of:

– Registration submission dossiers

– Pricing submissions

• Compliance and risk management in line with MoH regulations and laws, industry codes, and company policies

• Filing registration applications with the Turkish MOH 

• Coordinating GMP inspection priorities and schedules

• Monitoring your application with the Turkish MOH

• Obtaining final registration and Marketing Authorization

• Providing pricing assistance with the Turkish MOH

Marketing Authorization (MA) Holder

Guide you through the process of becoming a Marketing Authorization holder (MA), ensuring compliance and smooth regulatory procedures.

Project Management and Clinical Studies Coordination

• Planning, implementation, coordination, and project management of Phase I, II, III, and IV clinical studies and epidemiological studies on pharmaceuticals, vaccines, and medical devices.

• Consultation on research and development projects, including design, implementation, and project management of pre-clinical and clinical studies related to safety, efficacy, and cost-effectiveness of pharmaceuticals. 

Research and Development

• Design, implementation, and project management of R&D projects.

• Feasibility studies and reporting on the production of pharmaceuticals in Turkey.

• Pre-clinical and clinical studies related to safety, efficacy, and cost-effectiveness of pharmaceuticals.

• Feasibility studies and reporting on the production of pharmaceuticals in Turkey.

Training

• Medical trainings on specific disease and treatment areas, clinical studies (regulations, good clinical practice, guidelines, implementation), medical products, and medical devices.

• Health economics and pharmacoeconomics training.