Services
Product Development
Integrated development planning across CMC, nonclinical, and clinical functions — with ophthalmic endpoint, imaging, and operational specificity from preclinical through late-stage programs.
Ophthalmic development programs fail quietly when CMC, clinical, and regulatory workstreams drift apart — particularly for intravitreal biologics, sustained-delivery platforms, and combination products where delivery science shapes trial design and agency expectations.
BEEÑA-E supports sponsors in building integrated development plans (IDPs) that connect manufacturing scale-up, nonclinical packages, and clinical protocols to fundable milestones. We stress-test assumptions with regulatory and clinical operators who have navigated FDA and EMA interactions for novel ophthalmic modalities.
Endpoint and imaging strategy is central to our work. We align structural and functional outcomes to mechanism, precedent trials, and payer-relevant evidence — including OCT, microperimetry, visual acuity hierarchies, and patient-reported measures where appropriate. Early alignment reduces costly protocol amendments and supports consistent narratives for agencies and HTA bodies.
We advise on CRO and specialty vendor selection, ophthalmic core lab governance, and clinical operations planning for multi-country retina trials. Risk registers, critical path analyses, and scenario planning help leadership teams allocate capital with visibility into what drives timeline and probability of success.
Key outcomes
- Integrated development plans linking CMC, nonclinical, and clinical milestones
- Endpoint and imaging strategy aligned to regulatory precedent and payer relevance
- Protocol and statistical input for Phase 1–3 ophthalmic trials
- CRO and vendor selection criteria with ophthalmic capability weighting
- Development risk registers and critical-path scenarios for governance review
Frequently asked questions
Preclinical through Phase 3 and launch preparation. Early engagement is most valuable when delivery technology, endpoint strategy, or CMC complexity will shape the clinical path.
We map endpoints to mechanism and regulatory precedent, define imaging charter requirements, and align analysis plans with agencies and HTA expectations — including composite endpoints and hierarchical testing where justified.
Yes. We coordinate CMC, device, and clinical narratives for combination products and platforms where pharmacokinetics, depot behavior, and surgical administration affect trial design and labeling strategy.
Related services
Next steps
Discuss product development priorities
Confidential consultation with senior advisors on your ophthalmic program.