For expert guidance in pharmaceutical consulting, regulatory compliance, and risk assessment services, call us at +91 89859 18789.

ICH M7 Compliance Consulting Services

Comprehensive risk assessment services for pharmaceuticals are essential for ensuring regulatory compliance in the industry.

Get Expert Support

For expert guidance in pharmaceutical consulting, regulatory compliance, and risk assessment services, call us at +91 89859 18789.

ICH M7 Compliance Consulting Services

Comprehensive risk assessment services for pharmaceuticals are essential for ensuring regulatory compliance in the industry.

Get Expert Support

About Premier MedTech Solutions

Scientific formulas and DNA structure with chemical compound illustration.

Our Mission

We are a specialized pharmaceutical consulting company based in Hyderabad, India, dedicated to supporting pharmaceutical companies in navigating complex regulatory compliance requirements for genotoxic impurities and nitrosamines. With extensive expertise in ICH M7 guidelines and global regulatory frameworks, our team provides comprehensive risk assessment services, regulatory submission support, and strategic consultation to ensure your products meet the highest safety standards.

Contact Us

constact us at +91 89859 18789

For inquiries regarding our pharmaceutical consulting, regulatory compliance, or risk assessment services, please send us an e-mail at admin@premiermedtech.com.

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Premier MedTech Solutions

SBRS CV TOWERS, 2ND FLOOR, UNIT NO: 203, HUDA Techno Encalve Road, Madhapur, Hyderabad - 500081, Telangana, India.

+91.89859 18789

Hours

Mon	09:30 am – 05:30 pm
Tue	09:30 am – 05:30 pm
Wed	09:30 am – 05:30 pm
Thu	09:30 am – 05:30 pm
Fri	09:30 am – 05:30 pm
Sat	09:30 am – 01:30 pm
Sun	Closed

Premier MedTech Solutions

ICH M7 Compliance Consulting Services

ICH M7 Compliance Consulting Services

About Premier MedTech Solutions

Our Mission

our expert services

our expert services - ICH M7 COMPLIANCE

ICH M7 Compliance

ICH M7 Classification (Class 1-5)

(Q)SAR Analysis & Expert Reports

PDE, ADE,OEB,OEL Determination

Control Strategy Development

our expert services - NITROSAMINE RISK ASSESSMENT

Identification and Control strategies for nitrosamine impurities in pharmaceutical products

Nitrosamine Identification

Risk assessment and Control Strategies

Root cause analysis

Testing Strategy Development

our expert services - regulatory submissions

End to End support for regulatory submissions across global markets (US FDA, EMA, PMDA, TGA)

CTD Dossier Preparation

Expert Summary Reports

Query Response Supporty

Global Regulatory Strategy

our expert services - regulatory support & consultation

Proactive Support for agency interactions and comprehensive regulatory strategy development

Regulatory Agencty Query Support

Monograph vs (Q)SAR resolution

Audit Support and Gap Analysis

TRAINING AND WORKSHOPS

Contact Us

constact us at +91 89859 18789

Premier MedTech Solutions

Hours

ICH M7 Compliance Consulting Services

ICH M7 Compliance Consulting Services

About Premier MedTech Solutions

Our Mission

our expert services

our expert services - ICH M7 COMPLIANCE

ICH M7 Compliance

ICH M7 Classification (Class 1-5)

(Q)SAR Analysis & Expert Reports

PDE, ADE,OEB,OEL Determination

Control Strategy Development

our expert services - NITROSAMINE RISK ASSESSMENT

Identification and Control strategies for nitrosamine impurities in pharmaceutical products

Nitrosamine Identification

Risk assessment and Control Strategies

Root cause analysis

Testing Strategy Development

our expert services - regulatory submissions

End to End support for regulatory submissions across global markets (US FDA, EMA, PMDA, TGA)

CTD Dossier Preparation

Expert Summary Reports

Query Response Supporty

Global Regulatory Strategy

our expert services - regulatory support & consultation

Proactive Support for agency interactions and comprehensive regulatory strategy development

Regulatory Agencty Query Support

Monograph vs (Q)SAR resolution

Audit Support and Gap Analysis

TRAINING AND WORKSHOPS

Contact Us

constact us at +91 89859 18789

Premier MedTech Solutions

Hours

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