SERVICES OFFERED
We deliver comprehensive technical and regulatory support designed to enhance compliance and operational efficiency.
Quality Systems & Audits Readiness
Comprehensive system design and implementation to ensure site readiness.
- Quality Audits & Gap Assessment
- Quality System Design & Implementation
- Preparation of Site Master File
- Redressal & Gap Closure
- Design & Management of Special Projects
- End-to-end Laboratory Services
- Training: Audit Readiness, cGMP, GLP , CSA, CSB
- Human Error Reduction Programs
- Compliance & Productivity Improvement
Analytical Technical Support
Advanced method development and validation for precise analytical results.
- Analytical Method Development & Validation (API/FP on HPLC/UV)
- Cleaning Method Development & Validation (HPLC & LC/MS-MS)
- Bioanalytical Method Development & Validation (LC/MS-MS)
- Analytical Method Transfer & Verification
- Compendial Method Verification
Manufacturing Support
Ensuring robust manufacturing processes through rigorous validation and assessment.
- Cleaning Validation & Risk Assessment
- Manufacturing & IPQA Assessment
- Equipment Qualification & Validation
- Computer System Validation (CSV)
- Audit Handling & Compliance
- Implementation of cGMP at Site
- Risk Assessment Evaluation
Documentation & Automation
Streamlining regulatory documentation with smart, automated solutions.
- Macro-Enabled Word Templates
- Standardized Text Libraries
- 21 CFR Compliant Approval Process
- Dossier Compilation
- Document Translation & Enrichment
- Customizable & Cost-Effective Solutions
- Training & Support
Digitalization and Computer System Validation
High-level technical consulting for cloud security and system validation.
1. Pharmaceutical Validation
- Computer Systems Validation (CSV) & Assurance (CSA)
- Data Integrity (DI) Assurance
- Analytical & Manufacturing Equipment Qualification
2. Cloud Architecture & Security
- Designing & Deploying Secure, Scalable Cloud Applications
- Cloud Computing Security Assessments
- Cloud Security Best Practices (CCSK Expertise)
Six System Inspection Model
Compliance Readiness
Process Automation
Performance Growth
Data Integrity
Lab Services
Quality Audits
Our Story
ARM QualTech, founded by Dr. Manoj Rokade
ARM Qualtech pharmaceutical consultancy dedicated to strengthening manufacturing quality and driving operational excellence. Focused on Remediation, Data Integrity Assurance, and Productivity Enhancement, the firm delivers solutions across Quality Audits, System Design, Regulatory Compliance, Training, and end-to-end Laboratory Setup Services. With a strong emphasis on Automation, Process Optimization, and Gap Redressal, ARM QualTech supports organizations in building robust quality systems, ensuring compliance readiness, and achieving sustainable performance improvements in a highly regulated and competitive environment.
Our Mission
To empower pharmaceutical organizations with compliant, automated, and optimized quality systems that ensure regulatory readiness and sustainable operational excellence.
Our Vision
To be a trusted global partner in shaping resilient, future-ready pharmaceutical quality and compliance ecosystems.
Meet Our Experts
Dedicated professionals driving excellence
Dr. Manoj Rokade
Founder and CEO
Dr. Anirudh Vaidya
Chief Scientific Advisor
Mr. Dhirem Heisnam
Advisory Board Member– IT QA, DI, CSV and CSA (Europe)
Dr. Saleem Sheikh
Sterile Manufacturing & Quality System Expert
Industry Experience of Our Experts
We Deliver
We Impact
Achievements & Credentials
A legacy of scientific excellence and global expertise
Research Publications
In prestigious National & Multinational Journals.
Paper Presentations
Delivered at various scientific conferences.
Young Scientist
Best oral presentation at the Indian Council of Chemist.
Approved
Approval for Chemical & Instrumentation compliance.
Global Technical Expertise
AB SCIEX LC-MS Specialist
Trained in Application and Trouble Shooting by Applied Biosystems.
Locations: Dubai & Boston.
Merck KGaA Germany
Trained on Wellchrom Preparative HPLC for Isolation, Purification, and Characterization.
Get in touch
Dr. Manoj Rokade
Founder and CEO