EXCLUSIVE FEATURES FOR YOU

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Regulatory Strategy & Submissions

Regulatory Strategy Development

We co-develop regulatory strategies that align with your product's development goals and target markets (U.S., EU, UK, Israel, Australia and Africa). Our regulatory roadmaps are tailored for efficiency, compliance, and success.

 

Regulatory Affairs Consulting

We provide full-spectrum regulatory support including:

• FDA/EMA Orphan Drug Designation

• Fast Track Designation

• Breakthrough Therapy Designation

• Rare Pediatric Disease Designation (RPDD)

• IND, BLA, NDA filing

• Type A, B, C & D FDA meeting planning and representation

 

Gap Analysis

We conduct deep-dive evaluations to identify regulatory gaps and risks, ensuring your data package is submission-ready and aligned with agency expectations.

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Medical Device & Digital Health Regulatory Consulting

Medical Device Regulatory Affairs

Our expertise spans the full device lifecycle, including:

• FDA 510(k), De Novo, and PMA submissions

• EU MDR compliance

• SaMD and digital health product support

• Risk management (ISO 14971) and Human Factors Engineering

• Clinical Evaluation Reports (CERs) and Post-Market Surveillance

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Clinical & Non-Clinical Development Support

Protocol Assistance

• We provide clinical trial protocol development support using industry best practices and, through partners, offer access to AI-based tools (e.g., Protocol AI) to streamline design and improve outcomes.

 

Non-Clinical Study Management

• We support GLP-compliant studies including safety pharmacology, ADME, and toxicology studies, helping you meet regulatory expectations efficiently.

 

Clinical Trial Management

• Through regional experts and CROs, we help execute and manage clinical studies in India, the Middle East, and Africa—ideal for globally-conscious development strategies.

 

CDMO / CRO Consulting

• We help you identify and onboard the most suitable Contract Development and Manufacturing Organizations (CDMOs) and Clinical Research Organizations (CROs), from preclinical through Phase 3 trials.

 

Clinical Formulation & Batch Manufacturing

• Our network of CDMO partners enables formulation development for First-in-Human studies and GMP-compliant manufacturing of clinical batches for Phases 1–3.

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Business Development & Commercial Strategy

Due Diligence

• We perform rigorous evaluations of potential investments, licensing deals, and M&A opportunities. Our due diligence includes regulatory, clinical, and market assessments to guide high-stakes decisions.

 

M&A / Licensing Support

• Our network supports in-licensing and out-licensing deals with strategic guidance, valuation expertise, negotiation support, and contract development.

 

PRV Monetization

• We assist companies in monetizing their Priority Review Vouchers through strategic partnerships and competitive valuation models.

 

Fundraising Support

• We help clients raise capital to support preclinical and clinical development. Whether through non-dilutive grants or investor introductions, we guide you from pitch to funding.

 

Grant Writing

• Through our specialized partners, we help identify and apply for national and international grant opportunities, improving your chances of securing non-dilutive funding

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Sample of Current Projects

We support innovative health products across therapeutic areas and regulatory stages. Below is a snapshot of current engagements:

 

Pre-NDA & NDA Submission – Undisclosed cardivascular indication

• End-to-end regulatory support through NDA submission for an anti-inflammatory therapy.

Metastatic Melanoma

• Orphan Drug Designation (ODD),INTERACT meeting strategy and planning.

Growth Hormone Deficiency (GHD)

• Full support including ODD, Rare Pediatric Disease Designation (RPDD), Pre-IND meeting planning, and strategic fundraising/licensing advisory.

Rare Ophthalmologic Condition

• IND preparation and filing for a novel therapeutic in a rare eye disease.

INTERACT meeting coordination and regulatory guidance for an early-stage oncology asset

• T-cell Lymphoma - Small Molecule Program

Type C meeting and regulatory strategy development for nano-based delivery platform.

• Epidermolysis Bullosa Simplex (EBS)

Pre-NDA meeting and NDA submission

• Inflammasome/IL-1β-targeted therapy.

Ongoing fundraising and licensing advisory, helping biotech teams secure capital and strategic partnerships.

• Multiple Clients

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