Generics
Efficient Registration and Market Entry for Generic Pharmaceuticals
The demand for generic medicines is growing across Europe, driven by the need for cost-effective alternatives to branded pharmaceuticals. At Aequum we specialise in helping manufacturers of generic drugs navigate the complex regulatory landscape to achieve successful market entry in the EU. From dossier preparation to post-market surveillance, our team ensures that your generics meet EU quality, safety, and efficacy standards.
We are experienced in handling bioequivalence studies, technical documentation, and the stringent EU guidelines for generic drug registration. With our assistance, you can focus on delivering high-quality, affordable medicines to European patients.
Our Generics Services Include:
- Complete dossier preparation in accordance with EU guidelines
- Bioequivalence study management and regulatory submissions
- Risk management and post-market compliance
- Support with EU regulatory bodies for faster approvals
Aequum can be your trusted partner for securing swift approval for generics.