Biologics Consulting is thrilled to announce its Regulatory Affairs Business Unit. In an effort to better reflect the full depth and breadth of our regulatory expertise, we have renamed our Regulatory Project Management business unit to Regulatory Affairs. This brings a new name to our group of FDA regulatory SMEs as well as expanded service offerings for our clients that allow us to better support the full scope of regulatory lifecycle management.
Biologics Consulting can provide oversight and management in all phases of product development to ensure regulatory milestones are met. Our Regulatory Affairs experts:
- Advise on current FDA regulations, guidances and expectations based on regular interactions with the Agency.
- Provide regulatory strategy and submission guidance on FDA requirements for meetings and applications.
- Offer experience corresponding with FDA project managers and reviewers as the primary point of contact for Sponsors.
- Share regulatory intelligence with clients by staying current on new regulations that may impact product development.
- Lead the regulatory process in managing the writing and review of regulatory documents, coordinating strategy discussions, managing timelines, publishing and application maintenance activities.
- Advise on optimal practices to create efficient, reviewer friendly applications that meet regulatory requirements.
- The ability to fill an interim Full-Time Equivalent Regulatory Affairs role for Sponsors.
Our experts provide product development support for FDA meetings, original submissions and lifecycle maintenance for various FDA applications including:
- INTERACT
- Pre-INDs
- INDs
- NDAs (including 505(b)(2))
- ANDAs
- BLAs (including 351(k))
- Orphan Drug Designations
- US Agent or Regulatory Contact
- Expedited Regulatory Pathways (BTD, FTD, RMAT, Accelerated Approval, Priority Review, etc.)
Contact us to learn more or inquire about partnership.