Pharmaceutical Regulatory Consultancy — Tashkent

Regulatory certainty,
from submission
to certificate.

NSRP is a senior boutique consultancy specialising in pharmaceutical registration in Uzbekistan. We manage the entire pathway — strategy, dossier, authority engagement, and post-approval lifecycle — under one accountable partnership.

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Northern Star Regulatory Partners

A regulatory pathway is not a maze. It is a sequence — and a well-prepared sequence can be planned, communicated, and trusted.

12
Formal Stages
EN · RU
Bilingual
0
Surprises

What We Do

From first assessment
to market continuity.

01

Drug Registration

End-to-end registration of medicinal products in Uzbekistan, from pathway assessment and dossier preparation through authority engagement and certificate issuance. We manage all twelve formal stages on behalf of the marketing authorisation holder.

02

Medical Devices & Equipment

Registration of medical devices and equipment under Uzbekistan's regulatory framework. We advise on classification, prepare submission packages, and coordinate the technical review process with the relevant state authorities.

03

Bioequivalence Study Support

Regulatory advisory and dossier coordination for generic medicinal products requiring bioequivalence data. NSRP manages the regulatory dimension; study conduct is performed by partner clinical research organisations.

04

BAD / Dietary Supplements

Registration of biologically active dietary supplements (БАД) under Uzbek sanitary legislation. We advise on labelling, ingredient compliance, and submission requirements for both domestic and imported products.

05

Trademark Registration

Filing and prosecution of pharmaceutical trademarks with the Uzbek Intellectual Property Agency. Coordination with our specialist IP network ensures your brand is protected before and alongside product registration.

06

Post-Approval Lifecycle

Variations, renewals, labelling updates, and manufacturing changes across the full commercial life of a registered product. Regulatory continuity managed as a standing engagement, not a series of ad hoc requests.

The Northern Star Approach

We sell
certainty,
not paperwork.

Pharmaceutical registration in Uzbekistan unfolds across twelve formal stages governed by the Pharmaceutical Products Safety Center. The process is not, in itself, complicated. What is complicated is executing it precisely — and communicating it clearly — every time.

Every NSRP engagement is led personally by our Head of Regulatory Affairs. We do not operate as a processing house. We operate as a senior partner: assessing your product, selecting the optimal pathway, and holding accountability for outcomes throughout.

Predictable Timelines
Defined milestones at engagement outset. Written reporting against them. When statutory windows shift, you are the first to know.
Bilingual Reporting
All deliverables in English, with Russian versions on request. No information lost in translation between Tashkent and headquarters.
Direct Access
Principals are reachable directly. Decisions are made by those accountable for them — not delegated to junior associates.
Pathway Optimisation
Before any submission, we assess simplified recognition routes and expedited pathways. Where eligible, time and cost can be materially reduced.
“A regulatory pathway is not a maze. It is a sequence — and a well-prepared sequence is one that can be planned, communicated, and trusted from beginning to end.”
— Northern Star Regulatory Partners

The Registration Process

Twelve stages,
from submission to certificate.

General Procedure — Republic of Uzbekistan

The registration of a foreign medicinal product in Uzbekistan proceeds through twelve formal stages administered by the Pharmaceutical Products Safety Center. Each stage has a defined statutory window. Below is the sequence as it applies to most foreign products, with a note on how NSRP manages each stage on the client's behalf.

Standard Stage
Decision Gate
Certificate Issued
45
Days
I
Stage I

Dossier Submission & Payment

The applicant uploads the complete dossier to the official electronic system and remits the state registration fees. This window establishes the formal commencement of the procedure.

We prepare, validate, and submit the full dossier on behalf of the marketing authorisation holder.
30
Days
II
Stage II · First Decision Gate

Primary Expertise

Formal review of the completeness and authenticity of submitted documents. A procedural check, not a scientific evaluation.

We verify document completeness against the current regulator checklist before submission.
90
Max
III
Stage III

Remediation Window (if required)

Where deficiencies are noted, the applicant is afforded up to ninety days to address the regulator's observations.

Where remediation is requested, our team drafts and submits the response within days.
75
Days
IV
Stage IV

Laboratory Testing

Quality testing for identity, purity, content, dissolution, and dosage-form parameters at the designated state laboratory.

We coordinate sample delivery, customs clearance, and supporting documentation for analysis.
—
Parallel
V
Stage V

GMP Inspection Decision

Determination on whether a Good Manufacturing Practice inspection of the production site is required.

We assess inspection likelihood at engagement and prepare the manufacturing site team accordingly.
90
Days
VI
Stage VI · Second Decision Gate

Specialized Scientific Expertise

Quality, efficacy, and safety reviewed by Scientific Commissions composed of subject-matter experts.

Our regulatory team responds in real time to scientific queries raised during this review.
90
Days
VII
Stage VII

Clinical Studies Evaluation

Bioequivalence assessed for generic products; full clinical data examined for originator products.

We advise on study design ahead of submission to align with regulator expectations.
—
Within
VIII
Stage VIII

Scientific Commission Final Report

Findings consolidated into a formal evaluation report serving as the technical foundation for the decisions that follow.

We obtain and review the report to anticipate any issues raised at higher review levels.
15
Days
IX
Stage IX · Third Decision Gate

Committee Presidiums Deliberation

Senior reviewers issue a formal recommendation in favour of registration, or against it.

Where deficiencies are noted, we coordinate the response under the revised remediation window.
—
Sched.
X
Stage X · Final Decision Gate

Referral to the Expert Council

The regulator's highest deliberative body for marketing authorisation decisions reviews the recommendation.

We provide our client with a written briefing in advance of Council deliberation.
—
As Req.
XI
Stage XI

Pharmaceutical Inspection & GMP Certificate

National GMP certificate issued where a manufacturing-site inspection has been conducted.

We support the manufacturing site through inspection preparation and corrective action.
5 yr
Validity
★
Stage XII · Issued

Registration Certificate

The product is entered into the State Register of Medicinal Products of the Republic of Uzbekistan.

We deliver the certificate with a complete record of the procedure.
← Scroll to follow the journey →
A Note on Pathways

The General Procedure described here applies to most foreign products. Where a product holds prequalification by the World Health Organization, or has been approved by a regulator on the recognised list, a simplified recognition pathway may significantly shorten this timeline. We assess eligibility at the outset of every engagement.

The Partnership

Senior expertise,
personally engaged.

Managing Director & Head of Regulatory Affairs
Zulayho Yuldosheva
Co-Founder — Regulatory Lead

Zulayho brings deep expertise in pharmaceutical regulatory affairs in Uzbekistan and the broader Central Asian market. She leads every client engagement directly, managing dossier strategy, authority communication, and scientific review coordination. Her professional network spans the state regulatory system, clinical research institutions, and the regional pharmaceutical industry — built through years of senior practice in this market.

zulayho@nsrp.uz
Director of Operations & Business Development
Jorabek Jumanov
Co-Founder — Operations Lead

Jorabek leads client relations, commercial structure, and operational delivery at NSRP. He brings nine years of international professional experience across Boston, Los Angeles, and San Francisco — forming a client service orientation shaped by premium hospitality and management disciplines. He manages the technology infrastructure underpinning NSRP's reporting systems, and handles all commercial and pricing conversations on behalf of the firm.

jorabek@nsrp.uz

Begin a Conversation

Every engagement
begins with
a frank conversation.

We do not publish pricing. Each engagement is assessed individually, based on product type, dossier complexity, and the pathway selected. Reach Zulayho directly for regulatory enquiries, or Jorabek for commercial discussions.

We respond to all enquiries within four business hours during Tashkent working hours.

Send an Enquiry
Regulatory Enquirieszulayho@nsrp.uz
Commercial Discussionsjorabek@nsrp.uz
General Enquiriesinfo@nsrp.uz
Webnsrp.uz
OfficeTashkent, Uzbekistan