QMX

About Us

- An emerging and fast growing enterprise in Quality and Regulatory services.
- Established and run by SMEs.
- Dedicated and passionate team.
- Team is a perfect blend of experienced and fresh talents.

Our Services

GxP Consultation

GMP, GDP services provider.
Provided services to 60+ clients located in India and overseas.
Establishing and periodical monitoring of GxP systems.
Onsite and offline support.

Gap Assessment

Comprehensive review by subject matter experts (SMEs) across all functional areas.
Identification of gaps with respect to current regulatory and industry requirements.
Development of a structured and effective remediation action plan.
End-to-end support for implementation of the remediation plan.

Regulatory Support

Preparation and review of DMFs / Dossiers.
Regulatory audit preparation support.
Remediation support for regulatory observations.
Support provided for 20+ regulatory inspections including
inspections by USFDA, EU-GMP, WHO-Geneva, PMDA, KFDA.

Trainings

GMP and GDP trainings.
Customized training modules as per client requirement.
Training by SMEs with practical approach.
Onsite and virtual trainings.
Visit our website QMX Academy.

Third Party audits

Providing Third party audits by certified auditors.
Experience of 150+ audits for international clients.
Client specific audit reports.
Time-bound deliveries as per the commitment.
CAPA monitoring, as per the requirement.

Computer System Validation

Gap Assessment of Computerized systems.
Risk based approach for Computerized System Validation.
Life cycle management support.
Networking and Network Qualification.

Why We

• Providing quality services is our key objective.
• Quality manpower with immense knowledge in their respective areas.
• Services inline with the current updates in the industry.
• Documentation meeting the customer / regulatory requirements.

• Confidentiality in services.
• Customized services specific to client requirements.
• On-time delivery is our commitment.
• Quick response time and adaptability to changing client needs.

• Cost-effective solutions
• Efficient and effective project management
• Geographical advantage of locating in Hyderabad, the pharma hub of India.

Directors Profile

Amidhepuram Sudheer

Director - QMX Pharma LLP

Mobile: +91 98496 51776
E-mail: sudheer@qmxpharma.com

Experience

24+ years experience in Pharmaceutical Quality Assurance and Regulatory services.

Education

- Master of Science (Chemistry)
- Master of Business Administration (Quality Management)

Certifications

Certified Quality Auditor - ASQ
Certification Number: 72851
Certification date: 12/15/2021

Professional Memberships

- Member of ISPE (International Society for Pharmaceutical Engineering)
- Member of ASQ (American Society for Quality)
- Member of ECA GMP compliance academy