Regulatory strategy·Regulatory due diligence·AI model evaluation

Know the approval path before you commit the program.

Regulatory strategy consulting for drug development — partnering with clinical-stage biotech companies and the deal teams evaluating them.

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Available for contract, fractional, and advisory roles.

The core practice

Regulatory strategy

Most of the decisions that determine approval are made long before a marketing application is written — in how the development plan is built, which meetings are requested, and what a sponsor commits to in writing. We lead that work end to end, from the first regulatory milestone to the approval label.

Strategy & submissions

Global regulatory plans for individual assets and full programs tailored to development priorities
IND/CTA submissions for clinical trials across the product lifecycle
NDA/BLA/MAA filings led through Health Authority review, with an optimized global filing sequence
Core messaging for key module summaries and eCTD package preparation
Evaluation of expedited pathways and special designations
Probability of Technical and Regulatory Success (PTRS) assessment

Health Authority interactions & execution

FDA meetings, including Pre-IND, End-of-Phase 1 and 2, and Pre-NDA/BLA
EMA/CHMP Scientific Advice and national agency advice shaped to the development program
Advisory Committee meeting preparation
Briefing package authoring, question mapping, and defense rehearsal
Leading the interactions and translating agency feedback into program decisions
Managing critical issues and resolution with Health Authorities

Where the expertise extends

Due diligence and AI model evaluation

Regulatory due diligence & asset assessment

Identifying approval drivers, milestones, decision points, and regulatory risk in development plans.

Virtual data room review for acquisition and partnership targets, including regulatory correspondence and meeting minutes
Mapping a program's approval pathway and benchmarking it against precedent in the indication
Technical regulatory analysis of clinical-stage assets and scientific review of reported data
Assessment of whether the pivotal trial design supports the target product profile (TPP)

Scope of ServicesRelara Partners provides regulatory strategy consulting services, including technical regulatory analysis of drug development programs. We do not provide investment advice, valuations, price targets or recommendations on any security. Analysis concerning publicly traded companies is based solely on publicly available information. Where a transaction party provides access to a data room under a non-disclosure agreement, information received is used solely for that engagement.

AI model evaluation & improvement

Applying regulatory domain expertise to the evaluation and improvement of artificial intelligence models.

Benchmarking AI model outputs against regulatory and development ground truth
Building datasets to evaluate and improve how AI models perform on drug development tasks
Identifying where a model's reasoning breaks down on regulatory questions and how it can be improved
Constructing reference answers for regulatory questions with limited or no published ground truth
Testing whether a model's reasoning reflects actual agency precedent rather than plausible-sounding generic guidance

Who this is forAI developers seeking genuine regulatory domain expertise to evaluate and improve their models, and sponsors assessing whether an AI tool is fit for regulatory or development use.

How we work

Three ways to engage

Whether you need a deliverable, a function, or a sounding board. Scope is aligned before work begins and adjusts as program needs evolve.

Project

Typically four to twelve weeks, variable

A defined scope and a dated deliverable.

Typical work

FDA meeting briefing package, with rehearsal and defense planning
Submission-readiness gap assessment against current guidance
Regulatory due diligence review of a target or partner asset
Critique of a development plan before it is committed

Fractional

Typically one to three days a week, ongoing

Your regulatory lead, part-time — the function before the headcount.

Typical work

Acting head of regulatory affairs for a clinical-stage company
Ownership of an IND or CTA program across the lifecycle
Submission planning across a portfolio rather than a single asset
Standing representation on program and filing teams

Advisory

Typically a monthly retainer, or on call

Ongoing counsel for the decisions that cannot wait to be scoped.

Typical work

Briefings to the board and C-suite ahead of a financing or a filing
Strategy calls before a Health Authority interaction
A second opinion on regulatory correspondence or a review issue
Regulatory support through a transaction or partnership discussion

Not sure which fits? Most engagements begin as a project and move to a standing arrangement once the work proves itself.

About the Founder

Reena Nadpara, PharmD

Reena has 12+ years of experience in Global Regulatory Affairs, leading regulatory strategy and supporting drug development programs through Health Authority interactions, reviews, and approvals. She has led NDA submission teams and numerous interactions with major Health Authorities — including FDA, EMA, MHRA, and PMDA — and has navigated regulatory requirements across global regions. She has conducted due diligence evaluations for mergers, acquisitions, and partnerships. More recently, she has applied her regulatory expertise to evaluating and improving AI models.

Reena has worked across the industry, from large pharma (Allergan, Novartis, Gilead Sciences) to mid-sized biotech (MorphoSys, Nurix Therapeutics), where she served as the regulatory lead on program teams and helped shape critical development decisions. Her expertise spans multiple therapeutic areas and treatment modalities, with particular depth in oncology and hematology.

She brings a strong scientific foundation and a data-driven, pragmatic approach to complex development challenges. She collaborates closely with regulatory authorities, cross-functional teams, and co-development partners to translate regulatory strategy into actionable program plans.

Reena holds a Doctor of Pharmacy (PharmD) from Rutgers University, Ernest Mario School of Pharmacy and completed a postdoctoral fellowship in Global Regulatory Strategy at Allergan in affiliation with St. John’s University. She is based in the New Jersey / New York City area.

Reena Nadpara, PharmD
Principal Consultant and Founder

Know the approval path before you commit the program.

Regulatory strategy

Strategy & submissions

Health Authority interactions & execution

Due diligence and AI model evaluation

Regulatory due diligence & asset assessment

AI model evaluation & improvement

Three ways to engage

Project

Fractional

Advisory

Reena Nadpara, PharmD

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