Services

QbD-driven program design and execution support from hypothesis through IND and clinical phases

Services 

Collaborate with us: Request the non-confidential program synopsis and an NDA package for technical review.

 Partnering & Scientific Communications (NDA-ready)

Partnering & Investor Readiness (HIV Platform)

1) Investor Readiness

TPP-ready HIV platform seeking collaboration—Masinova provides the end-to-end program backbone (strategy, QbD/QMS, and execution governance) and partners with best-in-class labs/CROs/clinical sites to deliver IND-ready and Phase I–III packages under NDA.

2) Pharma Partnering Readiness (Licensing / Co-Development)

TPP-Ready Platform | Collaboration & Partner Enablement
Our HIV program is development-ready with a defined TPP and gated execution plan. We are actively seeking collaborators across preclinical models, CMC/analytics, and clinical operations to co-develop and advance the platform. Engagement is structured under NDA with controlled disclosure, clear work packages, and decision gates.

What we bring

  • TPP/QTPP finalized with endpoint logic and development gates

  • Integrated plan: preclinical → IND-enabling → Phase I–III execution pathway

  • QbD/QMS governance: controlled documentation, SOPs, QC review, audit readiness

  • Program management: project plan, RACI, risk register/RAID, vendor oversight

  • Diligence-ready packages: coherent evidence-to-claims crosswalk (post-NDA)

3) What we’re seeking

 

Preclinical execution partners (relevant in vitro/in vivo models, PK/PD, safety studies)

CMC/analytics partners (method development, potency/identity/purity strategy, stability)

Clinical collaborators (sites/KOLs, trial operations support, feasibility, biomarker sampling workflows)

Pharma/biotech partners for co-development, option/license discussions (as appropriate)

“Request Non-Confidential Synopsis” and “Request NDA”

1. Basic Tier—Foundational Scientific & Research Support

Ideal for: early-stage biotech startups, academics, or small companies needing targeted expertise.

Included Services

  • Literature & competitive intelligence review

  • Target assessment & validation reports

  • Proof of concept analysis

  • Scientific consulting sessions (1–5 hrs)

Deliverables

  • Executive summary report

  • Key research trends & competitive landscape

  • Recommendations & next steps

Price Range
$1,200—$5,000 per engagement

2. Professional Tier—Translational Development Support

Ideal for: companies needing hands‑on support through preclinical to clinicalplanning.

Included Services

  • Lead optimization strategy

  • Preclinical development plans

  • Regulatory gap analysis

  • Regulatory strategy consulting

  • Risk assessments & mitigation planning

Deliverables

  • Preclinical development roadmap

  • Regulatory briefing document

  • Project milestones & timeline

Price Range
$6,500—$15,000 per engagement

 

 

3. Business/Enterprise Tier—Full Preclinical & IND‑Enabling Services

Ideal for: biotech companies preparing for IND filing

Included Services

  • IND strategy & planning

  • Full regulatory documentation support

  • Quality‑by‑Design implementation

  • GLP/CMC consulting & execution oversight

  • Project management support from discovery → IND transition

Deliverables

  • IND/CTA briefing package

  • Master project plan

  • Risk register and corrective action plans

Price Range 
$25,000—$140,000+ depending on scope and deliverables

We offer à‑la‑carte services beyond packages

Service Unit Price
Literature review Per topic $900
Regulatory strategy memo Per project $2,000
IND readiness assessment Per assessment $5,000
Scientific advisory hours Per hour $150–$300
Scientific/Partnering slide deck refinement Per slide deck $1,500 – $5,000
Evidence map / competitive landscape refresh $2,500 – $8,000
Investor Q&A / diligence rehearsal session Per session $750 – $2,000
Ongoing program governance / PMO support (retainer) Per month $8,000 – $20,000
Clinical Trial Operations Plan (CTOP) + Integrated Project Plan Per plan $20,000 – $45,000
Risk Management Plan (Operational + Quality) Per plan $7,000 – $15,000
Clinical SOP Suite (GCP-aligned) + QC Review Per package $25,000 – $90,000+
Trial Budget & Resourcing Plan (Sponsor/CRO/site/vendored services) Per study $9,000 – $22,000

Beyond the ordinary

We provide end-to-end clinical trial support—from protocol concept through Phase I–III execution—covering study design, clinical operations, quality systems (QMS/SOPs), risk management, vendor oversight, and readiness for regulatory submission and inspection.