5 services
Product R&D and regulatory affairs
From concept to dossier: scientific planning and a regulatory-compliant submission
Taking a product from concept to authorization means planning the science and the regulation at the same table. We address product-specific decisions together with the requirements of the submission dossier, preventing unforeseen costs from the outset.
5 services
Science and regulation, on one platform
An experienced team follows your product through the safety and market-access stages as well. A decision made at authorization stays defensible in the reimbursement dossier.
- 01.1
R&D / product-development studies
Design, planning, execution and reporting of formulation, bioequivalence and drug-development studies. Projects are scoped to include GMP prioritization and clinical/non-clinical reports
- 01.2
Marketing authorization and approval dossiers
CTD dossier preparation, submission management and handling of correspondence with the authority
- 01.3
SmPC & PL preparation, clinical / non-clinical reports
Preparation and revision of the Summary of Product Characteristics and Package Leaflet in line with current guidelines
- 01.4
Medical device consulting
Consulting on medical-device classification, FDA submissions (510(k), De Novo, PMA, Pre-Sub, IDE) and EU MDR technical-file processes
- 01.5
Scientific publication review and medical writing
Preparation and review of clinical and non-clinical reports, scientific publications and technical documents such as white papers
- 01.6
Food supplements
Ingredient assessment, label and claim compliance, application dossiers and regulatory processes in Türkiye and the USA
Let’s plan your dossier together
Tell us what stage your product is at and we will come back with a scope and timeline.
Services
- 02
Safety and toxicological assessment
Toxicological assessment, exposure limits, product safety and impurity evaluation
- 03
Pricing and market access
We stay with you as clinical and economic value is turned into durable market-access decisions
- 04
Mentor Ar-Ge Academy