Strategic Regulatory Consulting
LBR’s Regulatory Affairs professionals provide a full range of strategic consulting services for pharmaceutical and biotech companies. This covers all stages of product development including preclinical, clinical, and manufacturing. LBR professionals develop efficient individualized strategies to navigate the development process. Sponsor costs can be significantly reduced by risk reduction and streamlining the development timelines.
As regulatory experts, LBR’s regulatory professionals are authorized to represent the Sponsor at meetings with the Food and Drug Administration (FDA).
LBR’s experience crosses many therapeutic areas.
These include, but are not limited to the following:
- Anti-viral (e.g., HIV)
- Medical Devices
- Rare and Orphan Diseases
- Surgical Indications
- Women’s Health
Regulatory Affairs Services Include:
- Strategic Regulatory Consulting in Preclinical, Clinical & Manufacturing
- FDA Liaison
- Guidance to Develop Optimal Regulatory Strategies
- Guidance on Evolving Regulatory Requirements
- Orphan Drug Pre-submission Meetings
- Pre-IND Meeting Assistance
- End of Phase 2 Meetings
- General Regulatory Advice Meetings