Roumnas BioLife

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Pharma

contract R&D

for global markets.

Pharma contract R&D

for global markets.

Pharma contract R&D

for global markets.

1999

Founded

Evolved into a full-fledged pharma contract R&D

company.

40+

Years of Research Background

Experience across major Indian pharma
companies and global development programs.

FDA / EMA

Global Market Support

Formulation development, analytical testing and
technology transfer.

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Founded in 1999, Sanmour supports global pharma customers with formulation development, analytical testing, technology transfer and consulting support.

Core strengths

Oral Solids

Taste Masking

Pelletization

Tech Transfer

Since 1999, Sanmour has expanded from a niche service provider into a full-fledged pharma contract R&D partner for global pharma customers.

Technology Transfer

New Product Development

Oral Solid Dosage Forms

Technology Transfer

Taste Masked Dosage Forms

Long Acting Dosage Forms

Generic ANDAs

Pelletization

Technology Transfer

New Product Development

Oral Solid Dosage Forms

Technology Transfer

Taste Masked Dosage Forms

Long Acting Dosage Forms

Generic ANDAs

Pelletization

Technology Transfer

About sanmour

Building reliable pharmaceutical solutions for global markets

Sanmour Consulting LLP supports pharmaceutical companies with formulation development, regulatory strategy, and analytical expertise. Our approach focuses on delivering robust, scalable solutions aligned with global regulatory standards.

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40+

Years of Research Background

Trusted by Leading Pharmaceutical Companies

Client Feedback

"Sanmour has been a reliable partner in supporting our regulatory and formulation programs. Their

structured approach and deep domain expertise have consistently delivered results."

"Sanmour has been a reliable partner in supporting our regulatory and formulation programs. Their structured approach and deep domain expertise have consistently delivered results."

"Sanmour has been a reliable partner in supporting our regulatory and formulation programs. Their

structured approach and deep domain expertise have consistently delivered results."

— Senior Director, Regulatory Affairs

Leading Indian Pharmaceutical Company

Why Sanmour

Trusted by Leading

Pharmaceutical Companies

Trusted by Leading

Pharmaceutical Companies

Trusted by Leading

Pharmaceutical Companies

We combine deep scientific expertise with global regulatory

knowledge to deliver measurable outcomes for our clients.

We combine deep scientific expertise with global regulatory

knowledge to deliver measurable outcomes for our clients.

We combine deep scientific expertise with global regulatory knowledge to deliver measurable outcomes for our clients.

Regulatory Expertise

Deep knowledge of FDA, EMA,

CDSCO, and other global

regulatory frameworks.

Deep knowledge of FDA, EMA,

CDSCO, and other global

regulatory frameworks.

Global Reach

Filings across 30+ countries with

market-specific regulatory

strategy.

Filings across 30+ countries with

market-specific regulatory

strategy.

R&D Excellence

End-to-end support from

preclinical development through

post-market surveillance.

End-to-end support from

preclinical development through

post-market surveillance.

Proven Track Record

200+ successful regulatory

submissions with high first-cycle

approval rates.

200+ successful regulatory

submissions with high first-cycle

approval rates.

Our Services

Comprehensive Pharmaceutical

Consulting Services

Comprehensive Pharmaceutical

Consulting Services

From early-stage drug development to market authorization,

we provide end-to-end support tailored to your needs.

From early-stage drug development to market authorization,

we provide end-to-end support tailored to your needs.

Regulatory Affairs

Strategic regulatory planning, dossier preparation, and submission

management across global markets including US FDA, EU EMA, and emerging

markets.

Clinical Development

Protocol design, clinical trial management, biostatistics, medical writing, and

pharmacovigilance support for Phases I–IV.

CMC & Analytical Development

Chemistry, manufacturing, and controls documentation, method development,

validation, and stability studies for drug substances and products.

Quality Assurance & Compliance

GxP compliance audits, quality system implementation, CAPA management,

and inspection readiness programs.

Medical & Scientific Writing

CTD modules, clinical study reports, investigator brochures, regulatory

responses, and publication support.

Market Access & Strategy

Pricing and reimbursement strategies, health technology assessments, and

lifecycle management consulting.

Inside Our R&D Environment

Our facilities and scientific infrastructure are designed to support efficient, high-quality pharmaceutical development across every stage of the product lifecycle.

From formulation development to analytical testing and process optimization, our teams operate within controlled, well-equipped environments that ensure precision, compliance, and consistency.

Our facilities and scientific infrastructure are designed to support efficient, high-quality pharmaceutical development across every stage of the product lifecycle. From formulation development to analytical testing and process optimization, our teams operate within controlled, well-equipped environments that ensure precision, compliance, and consistency.

Advancing Global Health Through Scientific Excellence

From formulation development to regulatory approval — we partner with pharmaceutical companies to bring life-saving therapies to patients worldwide.

Capabilities

Expertise Across the Pharmaceutical Development Lifecycle

Our multidisciplinary teams bring specialized knowledge

across every phase of the pharmaceutical lifecycle.

Our multidisciplinary teams bring specialized knowledge across every phase of the pharmaceutical lifecycle.

Drug Development

Preclinical development strategy

IND/IMPD preparation

Formulation development support

Bioequivalence & bioavailability studies

Biosimilar development consulting

Regulatory Intelligence

Regulatory landscape assessment

Competitive intelligence

Patent & exclusivity analysis

Labeling and packaging compliance

Post-approval variations & supplements

Operations & Compliance

GMP audit & remediation

Vendor qualification programs

Technology transfer management

Risk management (ICH Q9)

Data integrity assessments

Quality & Compliance

Commitment to quality and global regulatory standards

Sanmour follows rigorous quality systems and regulatory practices to ensure that every

development program meets international pharmaceutical standards.

Sanmour follows rigorous quality systems and regulatory practices to ensure that every

development program meets international pharmaceutical standards.

Our processes are aligned with Good Manufacturing Practices (GMP) and global

regulatory requirements, supporting submissions across US FDA, EMA, WHO PQ, and

CDSCO markets.

Our processes are aligned with Good Manufacturing Practices (GMP) and global

regulatory requirements, supporting submissions across US FDA, EMA, WHO PQ, and

CDSCO markets.

From formulation development to analytical validation and regulatory documentation,

we maintain a strong focus on accuracy, consistency, and compliance at every stage.

From formulation development to analytical validation and regulatory documentation,

we maintain a strong focus on accuracy, consistency, and compliance at every stage.

GMP-aligned processes

Regulatory-compliant documentation

Analytical validation and quality systems

Global regulatory expertise

Our Process

A Proven, Structured Approach to Every

Engagement

A Proven, Structured Approach to Every Engagement

Discovery &

Assessment

Discovery & Assessment

We begin with a thorough

evaluation of your

product pipeline,

regulatory landscape, and

strategic objectives.

Strategy Development

Tailored regulatory and

development strategies

aligned with target

markets and timelines.

Documentation &

Preparation

Comprehensive dossier

preparation, gap analysis,

and documentation to

meet global regulatory

standards.

Submission & Follow-

End-to-end submission

management with agency

liaison, query responses,

and approval tracking.

Post-Approval

Support

Ongoing lifecycle

management, variations,

renewals, and

pharmacovigilance

support.

Strategy Development

Tailored regulatory and development strategies aligned with target markets and timelines.

Documentation & Preparation

Comprehensive dossier preparation, gap analysis, and documentation to meet global regulatory standards.

Submission & Follow- Up

End-to-end submission management with agency liaison, query responses, and approval tracking.

Post-Approval Support

Ongoing lifecycle management, variations, renewals, and pharmacovigilance support.

Discuss Your Development and Regulatory Strategy

Connect with our team to review your formulation, regulatory, and development requirements and define a clear path forward.

Roumnas provides formulation, regulatory, and analytical support for pharmaceutical companies across global markets.

Quick Links

About Us

Services

Capabilities

Our Process

Services

Regulatory Affairs

Clinical Development

Quality Assurance

Market Access

Contact

info@sanmour.com

+91 7506650940

5A 21, Pareira Nagar,

CHS Khopat,
Thane (w) - 400 601 INDIA

Roumnas

Roumnas provides formulation, regulatory, and analytical support for pharmaceutical companies across global markets.

Quick Links

About Us

Services

Capabilities

Our Process

Services

Regulatory Affairs

Clinical Development

Quality Assurance

Market Access

Contact

info@sanmour.com

+91 7506650940

5A 21, Pareira Nagar,

CHS Khopat,
Thane (w) - 400 601 INDIA

Roumnas

Roumnas provides formulation, regulatory, and analytical support for pharmaceutical companies across global markets.

Quick Links

About Us

Services

Capabilities

Our Process

Services

Regulatory Affairs

Clinical Development

Quality Assurance

Market Access

Contact

info@sanmour.com

+91 7506650940

5A 21, Pareira Nagar, CHS Khopat,
Thane (w) - 400 601 INDIA

Roumnas