BioPharma Global
BioPharma Global is a mission-driven, not-for-profit regulatory affairs consulting firm dedicated to helping drug and device developers advance treatments for high unmet medical needs, especially in orphan diseases and rare conditions. They leverage FDA and EMA expertise to support regulatory designations, filings, and expedited programs, fostering long-term relationships with clients worldwide.
Industries
Nr. of Employees
small (1-50)
BioPharma Global
Vienna, Virginia, United States, North America
Services
Develop tailored regulatory development plans and strategies for product advancement with regulatory authorities.
Preparation and filing support for INDs, NDAs, BLAs, MAAs and other regulatory applications, including eCTD submission support.
Prepare and submit orphan drug, rare pediatric disease designation and related expedited-program requests to regulatory agencies.
Support for Investigational New Drug (IND) application preparation and formal FDA meeting requests, including pre-IND and other meeting preparation and attendance.
Provide guidance on eCTD structure and formatting and perform electronic submissions to regulatory authorities.
Regulatory strategy and submission support for medical devices and combination products, including IDE, PMA, 510(k), De Novo, HDE and classification requests.
Develop tailored regulatory development plans and strategies for product advancement with regulatory authorities.
Preparation and filing support for INDs, NDAs, BLAs, MAAs and other regulatory applications, including eCTD submission support.
Prepare and submit orphan drug, rare pediatric disease designation and related expedited-program requests to regulatory agencies.
Support for Investigational New Drug (IND) application preparation and formal FDA meeting requests, including pre-IND and other meeting preparation and attendance.
Provide guidance on eCTD structure and formatting and perform electronic submissions to regulatory authorities.
Regulatory strategy and submission support for medical devices and combination products, including IDE, PMA, 510(k), De Novo, HDE and classification requests.
Expertise Areas
- Regulatory strategy and compliance (FDA and EMA)
- Orphan drug and rare disease regulatory affairs
- Expedited program applications (Fast Track, Breakthrough, RMAT, Priority Review)
- Clinical trial protocol and pediatric study plan review
Key Technologies
- eCTD (Electronic Common Technical Document) submissions
- Regulatory dossier preparation and submission workflows
- Regulatory meeting briefing package development
- CMC documentation and regulatory CMC review methodologies
News & Updates
The FDA granted orphan drug designation to CellProtect, a natural killer cell therapy, for the treatment of multiple myeloma.
Over 350 applications submitted for FDA designations
The team has submitted over 350 applications for FDA Orphan Drug Designations, Fast Track, and Breakthrough Therapy, with a 100% success rate when following guidance.
The FDA granted orphan drug designation to CellProtect, a natural killer cell therapy, for the treatment of multiple myeloma.
Over 350 applications submitted for FDA designations
The team has submitted over 350 applications for FDA Orphan Drug Designations, Fast Track, and Breakthrough Therapy, with a 100% success rate when following guidance.