Biopharma global Review

About Biopharma global

BioPharma Global: Your Partner in FDA & EMA Regulatory Affairs

BioPharma Global is a non-profit corporation based in the United States that specializes in providing regulatory affairs services for orphan drug designations and related areas. The company has been operating for several years, and its team of experts has extensive experience working with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

At BioPharma Global, we understand that navigating the complex regulatory landscape can be challenging, especially for small biotech companies developing drugs to treat rare diseases. That's why we offer a range of services designed to help our clients achieve their goals while complying with all relevant regulations.

Our Services

Orphan Drug Designation: We assist clients in obtaining orphan drug designation from both the FDA and EMA. This designation provides various benefits, including tax credits, fee waivers, and market exclusivity.

Regulatory Strategy: Our team works closely with clients to develop a comprehensive regulatory strategy tailored to their specific needs. We provide guidance on clinical trial design, data analysis, labeling requirements, and more.

IND/CTA Preparation: We help clients prepare Investigational New Drug (IND) applications for submission to the FDA or Clinical Trial Authorization (CTA) applications for submission to EMA.

Clinical Trial Management: Our team provides support throughout all phases of clinical trials – from protocol development through study completion – ensuring compliance with all applicable regulations.

Marketing Authorization Application (MAA): We assist clients in preparing Marketing Authorization Applications (MAAs) for submission to EMA as well as New Drug Applications (NDAs) or Biologics License Applications (BLAs) submissions to FDA.

Post-Marketing Surveillance & Compliance: Our experts provide post-marketing surveillance support by monitoring safety signals through pharmacovigilance activities such as signal detection analysis; risk management plans; periodic safety update reports; benefit-risk assessments; etc., ensuring compliance with all applicable regulations.

Why Choose BioPharma Global?

At BioPharma Global, we are committed to providing our clients with the highest quality regulatory affairs services. Our team of experts has extensive experience working with both the FDA and EMA, and we have a proven track record of success in obtaining orphan drug designations and other regulatory approvals.

We understand that every client is unique, which is why we take a personalized approach to each project. We work closely with our clients to develop a comprehensive regulatory strategy tailored to their specific needs, ensuring that they achieve their goals while complying with all relevant regulations.

In addition to our expertise in regulatory affairs, we also offer competitive pricing and flexible payment options. We believe that everyone should have access to high-quality regulatory affairs services regardless of their budget or financial situation.

Conclusion

If you're looking for a partner in FDA & EMA Regulatory Affairs for orphan drug designations & other related services, look no further than BioPharma Global. Our team of experts has the knowledge and experience necessary to help you navigate the complex regulatory landscape successfully. Contact us today to learn more about how we can help you achieve your goals!