Product Development

Commercial and scientific assessment of R&D programs, technology platforms, and drug discovery portfolios. These assessments produce the analysis that underpins development decisions, fundraising, and investment. Engagements range from single-indication feasibility studies to multi-program portfolio prioritizations, and from early target validation assessments to comprehensive commercial development plans built to support venture financing.

• Indication selection, triaging, and prioritization across multiple candidates, scoring clinical opportunity, market attractiveness, development feasibility, and competitive differentiation
• Target Product Profile development that aligns commercial assumptions with what's achievable in the clinic and at the agency. The TPP is the anchor point for downstream development decisions
• Commercial opportunity characterization: patient population sizing, competitive landscape, pricing potential, peak sales modeling, and budget-to-launch estimates
• Path to market mapping with development timelines, cost estimates, and key risk identification at each stage

From target validation and candidate selection through IND-enabling studies and Pre-IND meetings. Preclinical consulting for small molecules, biologics, cell therapies, gene therapies, and other advanced modalities. For companies without internal preclinical teams, Alacrita can serve as the outsourced preclinical function: managing CRO and CDMO relationships, overseeing study execution, interpreting data, and preparing for regulatory interactions.

• Preclinical study design, including animal model selection, toxicology, safety pharmacology, and ADME, tailored to the specific modality and regulatory pathway
• CRO and CDMO selection, contracting, and ongoing oversight through study completion
• Data interpretation, preclinical study reports, and go/no-go decision support
• Pre-IND meeting strategy and IND submission preparation, including expedited pathway assessment (Fast Track, Breakthrough Therapy, PRIME, Orphan Drug)

Clinical strategy, protocol development, trial operations, and medical leadership from first-in-human studies through clinical proof of concept and beyond, matched to the therapeutic area and development stage of each program. Alacrita's clinical consultants are drug development physicians and functional specialists who write protocols, design and oversee trials, manage regulatory interactions, and provide independent data review. For companies that need ongoing senior medical leadership, Alacrita provides interim CMOs and medical directors who integrate with the team and carry the program forward.

• Clinical development plans, study synopses, and trial protocols, including endpoint selection, biomarker strategy, and patient enrichment approaches
• Clinical operations support: CRO and site management, recruitment strategy, clinical QA, and cGCP compliance
• Regulatory interactions from the clinical side, including IND/NDA/MAA readiness, agency meeting preparation, and expedited pathway applications (Fast Track, Breakthrough Therapy, Accelerated Approval)
• Interim CMO and medical director roles for companies building clinical programs without full-time senior medical leadership

Regulatory strategy and hands-on submission support from consultants with direct FDA and EMA experience, covering pathway assessment, agency interactions, designation applications, and the preparation and publishing of regulatory dossiers. Specialists include former agency staff and senior industry regulatory leaders across small molecules, biologics, and advanced therapies including cell and gene therapies. Alacrita also provides regulatory due diligence for licensing, investment, and M&A transactions.

• Regulatory feasibility assessment and pathway optimization, including expedited programs (Fast Track, Breakthrough Therapy, PRIME, Orphan Drug) and appeals of designation decisions
• IND/CTA preparation and submission, Pre-IND and scientific advice meetings, and NDA/MAA/BLA readiness
• Hands-on regulatory writing, eCTD publishing, and dossier management, not just strategic oversight
• Interim regulatory leadership and supplemental bandwidth for internal regulatory teams during peak periods or transitions

Pharmaceutical development strategy, CMC regulatory support, quality systems, and supply chain planning from early process development through commercial manufacturing, matched to the specific modality. Whether the program involves a small molecule, biologic, cell therapy, gene therapy, or other advanced platform, Alacrita's CMC specialists bring modality-specific experience in process optimization, CDMO management, and the regulatory requirements that apply at each stage. CMC due diligence for licensing, investment, and acquisition transactions is also a core capability.

• Process development, formulation strategy, analytical method development, and CDMO/CMO selection, contracting, and oversight
• CMC regulatory submissions (IND, NDA/BLA, agency interactions), including the additional complexity biologics and cell and gene therapies present
• Quality management systems, cGXP compliance audits, and preapproval inspection readiness for both FDA and EMA
• Supply chain design and implementation, from upstream manufacturing through downstream distribution, GDP compliance, and country-level regulatory requirements for commercial launch