For Biotech & Pharma
Your development plan is your valuation. Build one FDA and investors believe.
From indication strategy to IND and beyond, every raise funds a stage of your plan – and every stage either de-risks the next or exposes it. RCI Global Partners architects drug and biologic development strategy so your evidence, milestones, and capital are sequenced before you spend.
Who This Is For
Built for drug developers at the decisions that compound
Lead indication strategy
You’re defining your lead indication and need a development strategy that’s credible to FDA and fundable to investors.
Pre-IND engagement
You’re preparing for pre-IND engagement and want the meeting to settle your path, not multiply your questions.
Evidence sequencing
You’re sequencing preclinical and clinical evidence toward an IND – and every study has to earn its budget.
Reformulation & combination products
You’re developing a reformulation or combination product and the regulatory pathway is genuinely ambiguous.
Investor diligence readiness
You’re raising, and investors are asking development-plan questions your current materials can’t answer.
Milestones & capital planning
You need a development roadmap with stage gates, evidence milestones, and capital needs sequenced before you spend.
Sequence the program before you fund it
Drug development punishes improvisation. Programs stall when the indication shifts after the tox package is built, when the pre-IND meeting raises questions the team can’t answer, or when a raise closes against milestones that don’t actually de-risk the program. We sequence indication, evidence, regulatory engagement, and capital so each milestone genuinely earns the next – for the agency and for your investors.
what we do for biotech & pharma companies
Your regulatory strategy is the backbone of your development plan – and your valuation. IND, NDA, and combination products are where RCI’s drug-side depth sits.
- Pre-IND (PIND) strategy — meeting requests, briefing documents, and question design that gets you binding clarity, not open issues
- IND preparation and submission — assembled and sequenced so clinical start aligns with your funding milestones
- NDA strategy and market applications
- Combination products (drug + device) — a core RCI strength: pathway determination, center-jurisdiction strategy, and coordinated submissions across FDA centers
The fastest path to the clinic starts before the clinic – with a preclinical package built for your IND, not just for publication.
- Preclinical strategy — identifying the appropriate animal models and studies your IND actually requires, and developing the protocols to run them
- CDMO liaison — working with and coordinating contract development and manufacturing partners so your manufacturing track keeps pace with your regulatory track
- Clinical development plan design — phase sequencing, endpoint strategy, and evidence mapped to your target label
- Clinical protocol development and execution under IND — Study design that serves three audiences at once: the agency that approves you, the payers who will cover you, and the investors funding the next phase
Approval without access is a stranded asset. We build payer, provider, and adoption strategy alongside development – not after it.
- KOL identification and engagement for launch and advocacy
- Evidence planning that supports both your label and your value story
- Reimbursement and coverage strategy across Medicare, Medicaid, and commercial payers
We help founders build development plans investors believe in and secure the non‑dilutive capital that accelerates them — all backed by integrated regulatory, clinical, and commercialization guidance.
- Fractional regulatory and clinical leadership for teams without in-house functions
- Investor readiness: development-plan narratives, milestone roadmaps, diligence support
- SBIR/STTR and NIH grant support (Phase I, II, Fast Track) -including commercialization sections, regulatory strategy, timelines, and FDA-aligned clinical & CMC plans within submissions
Frequently supported program types
Therapeutic-area agnostic — these are simply where we’ve run programs most often.
1
Strategic Roadmap
Fixed-price, fixed-scope. Your sequenced plan in weeks. The default starting point.
2
Project Engagements
Milestone-based execution: submissions, study design and management, market access projects. Flat-rate packages available for common scopes (e.g., regulatory submissions, investor readiness).
3
Advisory Retainers
Ongoing fractional leadership from 15 hours/month.
“I’ve been working with RCI Global Partners for about a year on our FDA regulatory work. Knowledgeable, responsive, and effective.”
Joseph Nounou, MD
CEO, Auros Pharma (U.S.A.)
“Shaherah is one of those rare professionals who can translate regulatory complexity into clear, actionable strategy—and do it in a way that actually accelerates progress rather than slowing it down. Through our work together on the Capital Readiness Program, Shaherah has consistently brought critical insights and guidance that helped founders make smarter decisions, faster… Shaherah is someone you want in the room early and often.”
Heath Naquin
VP, Government & Capital Engagement, University City Science Center
Frequently Asked Questions
Find answers to the questions we hear most often about our services and engagement process.
When should we engage - before or after pre-IND?
Before. The pre-IND meeting is your highest leverage FDA interaction; the strategy should be settled before you request it, because the questions you ask determine the clarity you get.
Do you work on combination products?
Yes – drug + device combinations are a core practice area, including pathway determination across FDA centers.
We're an international company targeting the U.S. - can you help?
Yes. U.S. regulatory entry for international companies is a core practice.
We're pre-revenue and grant-funded - is this realistic?
Many clients are. We support SBIR/STTR and NIH submissions directly, and the fixed-price Strategic Roadmap is built for exactly this stage.
Do you replace our regulatory hire?
Until you need one full-time, yes – fractional regulatory and clinical leadership is a standard engagement model, and we’ll tell you when it’s time to hire in-house.