Billev Pharma East Ltd.
At Billev Pharma East, we offer a comprehensive range of services tailored to meet all your pharmaceutical needs. With over 15 years of experience, our expert team is committed to guiding you through various aspects of product development, regulation, and quality assurance, ensuring a collaborative and efficient path to success in the pharmaceutical landscape.
| Areas of Expertise | Details |
|---|---|
| Regulatory Affairs | We provide expert guidance on human medicines, veterinary medicines, medical devices, food supplements, cosmetics, and biocides. |
| Pharmacovigilance | Our services include vigilance for medical devices and comprehensive monitoring for both human and veterinary medicines. |
| Medical Consultancy | We assist in clinical studies and medical writing to support evidence-based practices. |
| Quality Assurance (GxP) | We ensure compliance with GCP, ISO, GDP, GMP, and conduct audits to maintain the highest quality standards. |
| Digital Consultancy | We specialize in electronic product information systems to modernize your operations effectively. |
Our mission is to simplify the complexities of the regulatory landscape and empower businesses through collaborative efforts with regulatory authorities, including all EU national competent authorities and the EMA. Our commitment to quality is reflected in our certifications, which include ISO 13485:2016 and ISO 9001:2015, ensuring that our services meet rigorous industry standards.
Our managing team comprises experienced professionals dedicated to delivering excellence in pharmaceutical consulting. With qualified experts in regulatory affairs, pharmacovigilance, and quality management, we ensure that every aspect of your project is handled with precision.
If you're looking for solutions that enhance your pharmaceutical practices, don't hesitate to reach out. Your success is our priority, and together, we can navigate the path to regulatory excellence.