We are dedicated to providing full solutions for marketing authorizations and fulfilling regulatory compliance.
We are here for our clients to overcome potential national regulatory obstacles and to prepare a strategy and support for pre and post-regulatory requirements.
With our experience and knowledge, we can assist you in all regulatory needs.
We provide regulatory services for:
- Medicinal products
- Medical devices
- Food supplements
We have years of experience acting as external Regulatory Affairs support by outsourcing and insourcing to
substitute in-house need for Regulatory Affairs personnel.
We have years of experience acting as external Regulatory Affairs support by outsourcing & insourcing to substitute in-house needs for Regulatory Affairs personnel.
A carefully planned and well-defined plan along with regulatory strategy is crucial in obtaining marketing authorization within expected timelines.
Our services include but are not limited to:
- Pre-authorization suport
- First registration and launch
- Continuous monitoring during the whole registration process
- Review dossier according to Act and Regulation
- Support Programme for import of samples of medical products
- Creation of text packaging material, Patient Leaflet, and Summary of Product Characteristics
- Compilation dossier