Getting Started

Who do you work with?
We support early-stage biotechs, academic innovators, translational teams, and venture investors. We’re most effective when nonclinical and translational strategy, investor readiness, or partnership preparation is needed.

What therapeutic areas and modalities do you support?
We’re therapeutic area– and modality–agnostic. Every project is designed around your target product profile and intended clinical use.

When is the best time to engage you?
From “promising findings, no clear plan” through pre-IND. We’re a strong fit once you have a defined target or asset and early data to evaluate—whether you’re advancing a program or assessing one.

Services & Deliverables

What types of services do you provide?

• Fractional R&D support

• Target and indication strategy

• Platform evaluations and prioritization

• Preclinical proof-of-concept and translational planning

• IND-enabling nonclinical roadmaps (toxicology, safety pharmacology, biodistribution, PK/PD)

• Study planning, CRO coordination, and oversight

• Investor readiness—narrative, deck, model input support, and data room structure

• Out-licensing and BD prep—One pager, FAQs, diligence checklists

• Scientific diligence for investors and BD teams

What deliverables should we expect?

• Target Product Profile (TPP)

• Nonclinical strategy readouts

• Model Species selection rationale and biodistribution/PK/PD plan

• Study reporting

• Nonclinical development timelines and budgets

• Risk and mitigation strategy

• Investor deck, Q&A guide, and data room organization

• BD materials—Opportunity Summary, diligence checklist, Pitch deck

• Diligence summaries or review memos (for investors or acquirers)

Do you run studies or manage vendors?
Yes—if preferred, we can manage nonclinical studies on your behalf. We handle planning, protocol development, CRO coordination, and oversight through to final readout. Alternatively, we can work alongside your team to support study execution. Either way, our focus is ensuring that work is aligned, efficient, and decision-relevant.

Boundaries

Do you represent clients to regulatory agencies (FDA, EMA, etc.)?
No—we don’t draft or submit regulatory packages or attend agency meetings. However, we will support writing the nonclinical sections of a regulatory document. We align development plans with guidance and precedent and work closely with your regulatory consultant.

Do you provide CMC support?
No—we don’t author CMC strategies or manage manufacturing workstreams. We coordinate with your CMC lead or external partner if needed.

Do you manage clinical operations?
No—we don’t design clinical protocols or run clinical trials. Our focus is on preclinical and translational strategy.

Engagement & Pricing

How do we get started?
We begin with an initial consultation. If there’s a fit, we’ll send a scoped proposal with timelines, deliverables, and pricing.

What pricing models do you offer?

• Fixed-fee projects

• Advisory meetings for rapid input or reviews

• Monthly retainers for ongoing support or fractional roles.

How long do projects typically take?
Timelines vary based on project scope, data readiness, and team coordination. We’ll establish expectations during scoping and adjust as needed.

What’s your communication cadence?
We tailor communication to fit the scope and pace of each project.

Can we pause or change scope?
Yes—projects are structured in phases. You can pause between milestones, and scope changes are handled with a short change note.

Confidentiality, IP & Compliance

Will you sign an NDA?
Yes—we’re confidential by default and sign mutual NDAs before reviewing materials.

Who owns the work product?
You do. All deliverables are assigned to you upon payment.

How do you handle data security?
We use secure platforms or your preferred data room. We can purge project data upon request.

Investor & Partner Support

Do you help with fundraising prep?
Yes—we help shape your story, review your pitch deck, structure your data room, and prepare for investor Q&A.

Can you support out-licensing or partnerships?
Yes—we help frame the opportunity, develop teaser and FAQ materials, and prepare diligence content.

Do you work with investors and BD teams directly?
Yes—we support VCs, investors, and BD teams with scientific diligence, translational feasibility assessments, and risk/return framing to guide investment decisions.

Fit & Logistics

Do you work with academic labs and translational centers?
Yes—we help translate academic discoveries into credible development plans and materials that support funding, partnering, or spinout formation.

Do you work with international teams?
Yes—we support programs worldwide.

How do we contact you?
Use the form on our site to request an initial consultation or send us an email at info@bridgelinetranslational.com.