Regulatory, Quality & Medical Affairs

“Solid documentation, traceable processes, predictable audit outcomes.”

We define the regulatory strategy for the markets of interest and prepare the technical documentation for the product. We design and maintain quality processes (product and process), including procedures, controls and traceability. We manage labelling and coding and provide Medical Affairs: scientific support for claims, literature review, essential clinical plans and post-market surveillance activities.

Product Development

We carry out a regulatory pre-assessment during the concept phase to precisely define the registration process in the target countries and avoid errors in the approach. We derive design requirements, testing/validation plans, and safety and performance criteria from clinical and usage needs. We coordinate prototyping, material/process selection, and packaging, keeping the design dossier and market access strategy aligned.
For supplements, cosmetics and medical devices, we manage formulation, safety assessment and labelling/claims in accordance with local regulations. This approach reduces rework and uncertainty, facilitating submission and market entry.

Market Access & Registrations

“Country strategy, submission package and end-to-end authority management.”

For each country, we define the prerequisites, plan the activities and prepare the registration package. We coordinate discussions with the relevant authorities, local document adjustments and post-approval deadlines. We cover the EU/UK, USA, GCC/MENA, China and other markets.

Transfer Tech

We transfer design dossiers and operational know-how to enable customers to manufacture in their own country. The technology transfer includes training, label and language adaptation, supplier qualification, and support for audits and inspections. The model is particularly suitable for medical devices and can be scaled to other segments.