Regulatory Expertise Privately-held consulting firm specializing in regulatory strategies for biopharmaceuticals from early development through Phase 3, led by a seasoned regulatory affairs professional with a proven IND filing track record, presenting a strong value proposition for companies seeking regulatory efficiency and expeditious approvals.

Biologics Focus Recent IND activity in cardiovascular biologics and extensive experience resolving CMC and toxicology requirements with FDA, suggesting target accounts in biologics development that may need milestone regulatory support, quality control, and submission readiness.

Small Firm Advantage Team size of 2–10 with deep niche expertise offers flexible, personalized regulatory services and potential upsell to larger sponsors through strategic engagement models, ideal for early-stage to mid-development programs seeking expert guidance without large CRO commitments.

Regulatory Problem Solving Strong track record in planning, drafting, and filing INDs with minimal holds, plus hands-on experience addressing CMC, potency method development, and carcinogenicity/toxicology negotiations, presenting opportunities to assist sponsors in remediation-heavy regulatory pathways.

Strategic Partnerships Location in San Diego biotech hub and existing FDA interaction history position Conventus as a potential partner for local startups and mid-size biotechs needing regulatory strategy, quality assurance, and biosimilar or combination product regulatory pathways to accelerate time-to-IND and IND-to-Phase progression.