Supplement development starts with the right ingredient. It continues with formulation, analytical review and a complete submission dossier. We bring these steps together for your brand.
Biontera is a subsidiary of Aymed İlaç Sanayi. We supply liposomal ingredients and branded supplement actives to manufacturers in Türkiye. Our formulation consultancy brings together ingredient selection, analytical review and dossier preparation.
We identify suitable liposomal vitamins and minerals, branded actives and botanical extracts for your product. We assess bioavailability data, use levels, technical specifications and supply requirements together.
Ingredient specification · Samples · Certificate of analysis
We define the intended user group, daily intake and dosage form. Ingredient compatibility, manufacturing suitability and permitted conditions of use guide the development of your formulation.
Ingredient selection · Daily intake · Capsule, tablet or liquid
We supply ingredients tested using HPLC and other methods appropriate to the ingredient, with supporting technical documentation. Where an applicable pharmacopoeial monograph exists, we use pharmacopoeial methods as a reference for identity, purity, assay and relevant quality controls.
Certificate of analysis (CoA) · Method information · Batch traceability
We bring the formulation, ingredient documentation, manufacturing records and analytical results together in a consistent dossier. Stability data, packaging, directions for use and label text are assessed according to the product’s requirements.
Formula and specifications · Quality documents · Label review
We prepare supplement dossiers against current requirements. With your authorisation, we submit applications to the competent ministry in Türkiye and follow their progress. Requests for additional information or corrections are addressed in the context of the complete dossier.
Application preparation · Dossier submission · Authority correspondence
For beadlet projects, we develop the formulation and layer structure, manufacture beadlets and fill capsules at our GMP-approved facility in Ankara Başkent OSB. Production steps are tracked through electronic records.
Multilayer structure · Size 00 plant-based capsule · Electronic records
We supply liposomal ingredients developed to enhance bioavailability. Liposomal structure, active content and absorption data are assessed as distinct aspects of each ingredient.
We review the manufacturer’s ingredient-specific structural characterisation. TEM images, particle size and encapsulation data inform this assessment.
HPLC, identity testing and relevant pharmacopoeial results are reviewed alongside the ingredient specification and batch certificate of analysis.
We review the formulation, dose and conditions used in comparative studies. Bioavailability results are presented with the research dossier for the selected ingredient.
We assess composition, analyses, labelling and claims together. Our work takes account of the Ministry of Agriculture and Forestry’s supplement application requirements and TİTCK’s health-claim rules within their respective scopes. We monitor regulatory developments and update dossiers against published requirements.
The competent authority is responsible for assessment and approval decisions.
Yes. We supply liposomal and branded ingredients and botanical extracts with technical files, samples and supply support. You can use our development services at the stages you need.
Yes. We review the formulation, ingredient documentation, analytical results and labelling together to identify gaps or items requiring an update.
You can request its specification, batch certificate of analysis, method information and available structural characterisation and bioavailability studies. Document availability depends on the selected ingredient.
It covers technical dossier preparation, label and claims review, submission to the competent authority with your authorisation and follow-up. We agree the scope at the start of each project.
You may be sourcing an ingredient, developing a new formulation or completing an existing dossier. Tell us what you need, and we will define the scope together.