Our Services
Research and Development for Healtcare Industry
- Design, project planning, implementation and reporting of R&D
and product development studies - Formulation, bioavailability, bioequivalence, preclinical and
clinical studies - Identifying national and international strategic solution partners
- Preparation of scientific publications, technical documents
(white paper) and presentations
Assisting Drug Licensing and Regulatory Affairs
- Preparation of licensing/regulatory approval files and
applications
° Preparation of non-clinical and clinical reports
° Preparation of Summary of Product Characteristics and
Package Insert - Preparation of product-specific scientific reports
- Preparation of prioritization evaluation and exceptional licensing
applications - GMP prioritization
- Application for marketing authorization
- Early access to medicine application
Safety Assessment
- Preparation of safety assessment and toxicology reports
- Calculation and reporting of PDE/ADE/OEL values
- Toxicological evaluation of impurities
- Consultancy services in post-marketing authorization safety
studies - Preparation of Safety Data Sheet (SDS) for raw materials
Market Access and Reimbursement
- Consultancy on national and international market access and
reimbursement system - Market analysis, product selection
- Preparation of reimbursement application files for drugs/
medical devices - Preparation, adaptation and reporting of pharmacoeconomic
analyses and models - Budget impact analyses and reporting
Pharmaceutical Pricing
- List price application
- Notification and changes of reference prices
- Studies on highlighting the clinical value of the product and
maintaining a sustainable price level
Cosmetic Products
- Preparation of safety reports for cosmetic products
- Definition and evaluation of the toxicological profile of cosmetic
product components - Consultancy services in cosmetovigilance studies
- Execution of approval processes for cosmetic products in Türkiye
and USA
Food Supplements and Athlete’s Health Products
- Supporting of approval processes for food supplements in
Turkey and USA - Consultancy on production and management processes of
athlete’s health
Medical Devices
- Supporting of approval processes for medical devices in Türkiye
and USA - Toxicological risk assessment in medical devices
- Preparation of Medical Device Regulation (MDR) files
Speciality services in Pharmacy
- Strategic support for entrepreneurial pharmacists
- Support for scientific and professional development
- Consultancy on alignment with current health services and
technological developments - Support for innovational digital health and promotion activities
in accordance with the regulations
For Consultancy Services,
Contact Us
With our extensive years of experience in the industry, we can provide you with the best service at every stage of the drug development process. By working with us, you can minimize the risks in the drug development process and enhance the success of your product.