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GMP AUDIT

Third Party Suppliers Audit services for QP

Benchmark Risk Assessment Reports

(Compliance with Pharma and Global regulatory requirements)

DISSERTATIONS/ VOCATIONAL TRAININGS /PROJECTS

[APPLICATIONS ARE INVITED FROM COLLEGES & UNIVERSITIES RESEARCH STUDENTS]

(M.Sc./ Pharm / M.Pharm / Diploma Science Streams)

QSAR Software ICH M7 (Statistical & Expert ruled based report)

Structural alert Risk Assessment Report in line with USFDA/EDQM/ ICH M7/ICHQ9

UKRT/ERT/ETS-TOXICOLOGIST CERTIFIED REPORTS (ADE/PDE/OEL/MDD)

ISO Certifications and renewals

(Our associated ISO Auditors provide best and quick services)

Mendel Genetics India Profile

About

Mendel Genetics, provides regulatory solutions in the field of Pharmaceuticals regulatory DMF/ANDA submissions & effective Query response. Genotoxic Impurities (GTIs) assessments, particularly adhering to the ICH M7 guideline.

The company's services focus on evaluating potential genotoxic impurities in pharmaceutical compounds using advanced computational techniques like (Q)SAR (Quantitative Structure-Activity Relationship) software. These regulatory solutions aim to support pharmaceutical companies by ensuring compliance with international guidelines, minimizing the risk of genotoxicity in drug substances, and ensuring that the impurity assessments meet regulatory requirements. By offering expert structural assessments at affordable rates, Mendel Genetics helps clients navigate the complex landscape of pharmaceutical regulations, making their products safer and more compliant with global standards.

Pharmaceutical services

Mutagenic impurities (ICH M7), Solvents compliance (ICH Q3C) Quality Risk Assessment Reports Preparations as per ICH Q9
Structure-activity relationship (SAR) and quantitative structure-activity relationship (QSAR) Expert Rule based and Statistical based bacterial end point mutagenic report to complying ICH M7 and regulatory requirements with the most competitive price. We recommend the further control strategies too for further actions requirements, which makes us unique among other service providers.
We support to customers for the Fate & Purge studies as per ICH M7 Option-4 as per regulatory requirements.
We support the new sites set up and qualifications requirements like AHU/HVAC documentation.
GMP ICH requirements, Specification design for RM/KSM/Intermediate Manufacture.
Drug Master File Preparation and submissions (Only for APIs)
Support and pin point guidance for the Drug Substance regulatory queries and deficiencies.
Technical Support the customers for CEP 2.0 requirements and SPOR & ORG ID related update.
We support customers to redefined starting materials & justification which is a frequent deficiencies for Drug substance by almost all the regulatory agencies. (Information given in EDQM sites)
We support the customers for their requirements of ICH Q1, ICH Q2, ICH Q3C.
Support and guidance for switching from CTD to eCTD & Life cycle management
We have CQI-IRCA certified GMP auditors for external audit support for global and national customers.
Support the updataion in QMS and total Quality Management System.

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

Services available for analytical support click below for Mendel Genetics Pharma Solutions

https://site-5125dz2qm.godaddysites.com

Email on t1.mendelgenetics@rediffmail.com for analytical requirements & testing

Other Pharmaceuticals Services

Computer System validations, Third Party Audits, GMP Setup, GAP Analysis

Membership

Member of European Society of Toxicology In Vitro (ESTIV)

Member of TOXICOLOGIST OF INDIA-TOXREGISTRY

FAQs

Q 1: Is Genotoxic risk assessment is mandatory for API registrations in US, Canada, Europe CEP.

Ans. Yes, you can see the DMF 3.2.s.3.2 where agencies are mandatory asking for Genotoxic Impurities risk evaluation and control strategy before grant of marketing Authorization and CEP approvals.

Q 2 : Is it acceptable to share declarations by KSM and intermediate as "No Genotoxic imp in ROS"without QSAR test

Ans. Yes, but for many complex structures suppliers required QSAR to check Mutagenic positive or Negetive, hence it is recommended to do QSAR for all structures in ROS from KSM till API, to avoid any Regulatory deficiency in associated dossiers.

What We Do

100% Success rate of our submitted risk assessment report for accuracy & adequacy of content & scien

Commitment to Provide affordable services

Our company understands the current CEP, USFDA & other global regulatory Dossier filing requirements where Genotoxic Impurities quality risk assessment & QSAR software based identification are major focus area for pharmaceutical industry and it is consistently increasing towards fate & purge studies. Our team of experienced quality assurance, R&D and Regulatory affairs professionals stays current & support for the latest regulatory requirements to avoid deficiency.

Contact Us

GSTIN is 24AXIPB5024C1Z7

Mendel Genetics India Office:Mendel Genetics India Office:

MSME Certificate :UDYAM-GJ-24-0159472

Director : Ms. Neeraj Bhatt (Pharmaceutical)

Address : E-304, Shreenath Puram, Nizampura, Vadodara, India

India

✉️ mendel.genetics@outlook.com

🍁CANADA OFFICE:

Brampton, Ontario,Canada,

✉️: mgrs@mendelgenetics.in

Message us on WhatsApp

🌐 www.mendelgenetics.in

Vadodara, Gujarat, India

Mendel Genetics Regulatory solutions ☎️ 919327058062 📬Address : E-304, Shreenath Puram, Nizampura, Vadodara, India ✉️ mendel.genetics@outlook.com ✉️ neeraj.mendelgenetics@gmail.com email: mgrs@mendelgenetics.in

Hours