Quality and Regulatory
Sustainability is at the heart of everything we do, integral to our service offerings and business operations. Our mission is to extend our core values to as many partners as possible. By collaborating closely with our global affiliates, we strive to reach and support our clients worldwide.
Commitment: We are experienced, passionate, and dedicated professionals who take pride in our work.
Compliance: Consistent oversight by competent authorities ensures our continuous compliance with national and international cGXP regulations and industry trends.
Regulatory Affairs
We provide extensive regulatory and medical support services for human medicinal products and US over-the-counter (OTC) products within the USA. From dossier compilation and monograph creation to registration and ongoing lifecycle management, our team of business-minded professionals ensures meticulous attention to detail while also considering the implications for costs and timelines.
Our objective: The fastest approval at minimal costs.