Company Overview
At Pharmorra-Technical Consulting, we empower pharmaceutical companies to achieve global regulatory approvals with confidence. With over two decades of combined expertise, we deliver end-to-end consulting solutions in GMP compliance, Calibration/Validation, CSV and Toxicological studies, technology transfer, pharmacovigilance, and regulatory affairs.
Our Mission
To provide cost-effective, high-quality, and innovative pharma consulting services that ensure compliance, enhance operational efficiency, and enable access to international markets.
Our Vision
To be the most reliable partner for global pharmaceutical companies, driving quality, safety, and regulatory success.
Our Leadership Team
Mahendra Sharma
Founder Director – Pharmorra Technical Consulting(2025–Present)
Core Expertise 28+ years exclusive experience in Sterile Injectables formulations (SVP, LVP, Lyophilized products, Pre-filled Syringes, Ampoules, Biologics) End-to-end expertise in Production Operations, Process Optimization, Technology Transfer, Scale-up, Regulatory support: USFDA, EU-EMA, WHO, PIC/S, ANVISA, MCC, TGA, MHRA 200+ vendor/supplier audits conducted globally Greenfield & brownfield project execution for Sterile, OSD & Biological facilities Previous Organizations Nicholas Piramal, Pfizer India, Dabur Pharma, Ajanta Pharma, Eris Bionxt. Etc.
Key Achievements Successfully guided 25+ sites/clients for USFDA, EU & WHO approvals with zero critical/major observations in the last 28 years Established sterility assurance programs with 100% media fill success rate across multiple facilities Led end-to-end greenfield sterile projects (cleanroom design to commercial production) Optimized aseptic filling lines resulting in 25–40% increase in line efficiency and yield Resolved multiple USFDA Form-483s & Warning Letters through scientific remediation Major Responsibilities Delivered
Production operations leadership: Aseptic filling, lyophilization, terminal sterilization, PFS lines Process optimization & yield improvement for high-value biologics and complex injectables Facility design review & qualification (cleanrooms, HVAC, water systems, isolators/RABS) Aseptic process validation, media fill design & smoke studies Risk-based vendor qualification & audit programs Mock audits, regulatory inspection hosting & readiness Training faculty: GMP, EU Annex 1, Data Integrity (ALCOA+), Contamination Control Strategy
Jaideep Katarey
Founder Director – Pharmorra Technical Consulting (2025–Present) Certified Lead Auditor (IRCA)
Core Expertise 21+ years exclusive experience in Sterile Injectables (SVP, LVP, Lyophilized, Pre-filled Syringes, Biologics) Expert in QA, QC, Microbiology, GMP, Data Integrity & Regulatory Compliance Regulatory support: USFDA, EU-EMA, WHO, PIC/S, ANVISA, MCC 400+ vendor/supplier audits conducted globally Greenfield & brownfield project execution : Sterile, OSD & Biological facilities. Previous Organizations: Cipla, Zydus, Akums, Eris Bionxt. Etc.
Key Achievements Successfully guided 50+ clients for USFDA, EU & WHO approvals with zero critical/major observations in last 10 years Designed & qualified EU Annex 1 compliant aseptic facilities (Isolators/RABS) Established sterility assurance programs with 100% media fill success rate Led QC/Microbiology labs Established sterility assurance programs with 100% media fill success rate across multiple facilities Major Responsibilities Delivered Facility design review & qualification (cleanrooms, HVAC, water systems) Aseptic process validation & media fill design Risk-based vendor qualification & audit programs Mock audits & regulatory inspection readiness Training on GMP, Annex 1, Data Integrity, Contamination Control Strategy
Vaibhav Patel, RAC-US, ASQ CQA
Director Technical Expert – Quality Assurance & Regulatory Affairs
leader with 14+ years of experience across biopharmaceuticals, radiopharmaceuticals, nanoparticle-based therapies, cell and gene therapies, and monoclonal antibodies. He has led and built phase-appropriate Quality Management Systems supporting FDA Phase I & II IND programs, clinical manufacturing, and advanced therapy development.
Vaibhav has extensive hands-on expertise in cGMP, GTP, GCP, GLP, FACT, and ICH standards, with a proven track record in QA oversight, regulatory strategy, IND CMC review, CDMO selection and auditing, cleanroom environmental monitoring, deviations, CAPA, stability programs, and equipment qualification (IQ/OQ/PQ). He has successfully partnered with academic institutions, biotech startups, and global pharmaceutical organizations to ensure regulatory compliance, patient safety, and data integrity.
Currently serving as Director of Quality Assurance and Regulatory Affairs, Vaibhav collaborates closely with scientific, medical, and operational leadership to support clinical product manufacturing and regulatory readiness. He is also a published author, industry speaker, peer reviewer, and active contributor to professional standards organizations, bringing a balanced perspective of science, compliance, and real-world execution to quality and regulatory leadership.
Dr. Elango Minnoor, M.S., Ph.D., M.B.A.
Director Technical Expert – Manufacturing & Global Operations
Dr. Elango brings over 25 years of distinguished experience across biologics, injectables, and device manufacturing, with a proven track record of leading large-scale operations and global contract manufacturing networks. His deep expertise in cGMP, quality systems, and regulatory compliance (FDA, EMA, PMDA, MHRA) has consistently enabled organizations to achieve successful inspections and sustainable operational excellence.
During our engagement, his strategic insights and hands-on approach significantly contributed to optimizing manufacturing efficiency, strengthening quality systems, and enhancing global supply chain performance. His ability to seamlessly integrate technical knowledge with business strategy makes him an invaluable partner for complex pharmaceutical projects.
Dr. Elango’s leadership in areas such as technology transfer, process optimization, audit readiness, and medical device commercialization ensures that clients receive practical, high-impact solutions aligned with global standards.
Why Choose Us
Worldwide Presence
Supporting pharma companies across regions with regulatory expertise.
Proven Partnerships
Trusted by clients for successful outcomes & long-term growth.
Smart & Tailored Solutions
Delivering cost-effective and innovative consulting approaches.
Deep Domain Knowledge
Decades of experience across diverse pharma operations & markets.
