HITENDRAKUMAR SHAH (CEO)
Pharmaceutical Compliance Consultant,
cGMP Trainer & Auditor
MEGHA SHAH (MD)
Pharmaceutical Event Organizer, Automation(PLC/SCADA) support and Validation Engineer
HITENDRAKUMAR SHAH (CEO)
Pharmaceutical Compliance Consultant,
cGMP Trainer & Auditor
MEGHA SHAH (MD)
Pharmaceutical Event Organizer, Automation(PLC/SCADA) support and Validation Engineer
Mr. Hitendrakumar Shah – A Quality oriented professional with over 25 years of experience in Quality Assurance, Quality Control, Quality engineering, Quality auditor, pharmaceutical regulations and regulatory audit compliance.
During tenure audited more than 500 vendors/suppliers and trained more than 10000 candidates.
The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.
The key competencies include, Quality Compliance, Supplier Audit, build systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post approval queries raised by regulatory agencies etc.
Independently handled – Quality assurance and Quality Control department for more than 13 years.
Audits faced- USFDA (8 times), ANVISA, MHRA, MCC, TGA,IDMA excellence, WHO audit, EU regulatory (9 times) , Yemen MOH, Digemid (Peru), Russian Authority audit etc.
The experience is for medical devices, OSD, Small volume injection Sterile, Hormones and potent molecules, Cephalosporins etc.
Mrs. Megha Shah – An electronics & Telecommunication engineering professional actively involved as Pharmaceutical Event Organizer, Automation engineer and Qualification expert.
An engineering professional over 15 years of experience in industrial automation and Qualification.
Mrs. Vasundhara Ramaiyengar – A result-oriented Pharmaceutical Quality professional with 25+ years of experience in pharmaceutical companies. A Leader passionate about Team Management, Quality and experienced in Quality assurance, Quality Control, Analytical Development, QMS implementation and compliance, External Quality (Contract Manufacturing and API supplier management), Auditing, Training, Site Quality Remediation, Corporate Quality , Regulatory compliance, Product Life cycle management (Process Validation) Green Field Projects.
Supported in establishing AstraZeneca’s Worldwide Audit group (WWAG) global organization in Asia Pac. I have established the Internal Audit system and Training system, trained the self-Inspection and Global Audit team members on Audit Principles, Audit Techniques, Data Integrity, QMS audits.
An expert IRCA Certified Global Quality/GMP Auditor, with valuable supplier auditing experience in APIs, Formulations, excipient, chemical, Packing material industries (manufacturing & packaging), Competent in cGMP concepts of US-FDA, MHRA and Indian Drugs & Cosmetics Act for drug substance and drug product manufacturing. I have done Audits across Asia Pac (India, China, Singapore, Indonesia, South Korea, Japan, Australia, and New Zealand) and Europe.
Mr. Dirgeshkumar Patel – Quality Head with more than 22 years of rich & qualitative experience in Pharmaceutical Industry.
Having experience in the dosage form (Sterile and non-sterile Manufacturing) like Oral solids, Injectable, Semi-Solid, Ophthalmic solutions, NDDS formulations and MDI, Combination product.
Experience in dealing with third party Quality like CMO CRO, CDL and CTL, Expertise in investigations such as OOS, OOT, Deviation & Incidences with compliance and trending, Ensure Compliance of Third-Party operation and Pharmaceuticals Audits (API endor, CMO, CRO and Contract Testing Lab, Device manufacture), Participate in developing CMO and CTL and getting ready for PAI, New Product Launches (Validation and commercial batches) Proven excellence by challenging & implementing Validation and Quality Assurance Strategies through risk-based evaluation and decision making, Expertise with regulatory audits such as USFDA, MHRA, TGA, WHO, Canada, ANVISA to name a few; passed various audits successfully at Ranbaxy Ponta Sahib Plant (Sun Pharma), Cadila Pharma, Dholka Plant and Famy Care, Ahmedabad & Sarigam Plants, till date all the audits have been successfully completed without any major concern, Established key process indicators (KPI’s) and implemented preventive & corrective actions to eliminate the root causes of poor quality and delivery,
Contributed to the improvement of life quality & advancement of mankind through innovative solutions & formulations with analytical method development and quality evaluation of drugs & its products, Expertise in managing quality documentations, Team-based management style coupled with the zeal to motivate subordinates with exceptional leadership skills in heading global teams.
Mr. Manish Kamble – Career oriented Regulatory professional with 20+ years of Industry experience including GMP compliance.
Regulatory professional with substantial expertise in Global Regulatory filing, Life cycle management, Project Management, Regulatory Strategy and Regulatory and GMP compliances.
Experience in implementation of regulatory strategy, closely work with business development as a Regulatory project management support and commercialization of products with various clients.
Experience in Regulatory liaison to work and deal with cross functional teams, consulting and external business partners on sourcing administrative and technical documents, resolving queries and conflicts, customer complaints and timely approvals.
Expertise in CMC documentation, variations, renewals, change control assessment, gap analysis, publishing for global markets.
Handled eCTD softwares, Veeva Vault for initial filing, life cycle management, change control assessment.
Consulting for EU GMP inspections from HALMED Croatia and Liaising part of various clients till getting EU GMP certificate.
Overall experience in Regulatory affairs, regulatory strategy for initial and post-approval changes, align with business development activities and Regulatory and GMP compliances.
Mr. BH. Koti – A dedicated Professional with over 20 years of cross functional experience in Highly Regulated FDA environments focusing on Quality Control Laboratory Operations, Quality Management Systems, Analytical Method Validations, Stability Studies, Regulatory Compliance and Data Integrity Compliance in the Pharmaceutical and Biotech Industries. Independently held various positions at Dr.Reddy’s Labs, Micro labs, Wockhardt Ltd and Cipla Limited.
Proven knowledge in implementation of Regulations as per of USFDA, PMDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M ,Data Integrity Compliance Systems, Electronic Records, Electronic Signatures (21 CFR Part 11) in Pharma Industry.
Excellent communication with strong analytical, problem solving & leadership abilities. Consultant and Trainer for many pharma companies such as Sandoz, Wockhardt, Hetero labs, Neuland Labs,Indian Immunological Ltd,Aristo Pharma, Merck,AET Laboratories, Naprod Life Sciences Mumbai, MAC-Chem, Famy care Ltd, Axar Pharma(USA),Medicef Pharma,IPCA Labs, Calyx Pharma,Srikrishna Pharma,Milan Labs, Sapphire pharma, Samarth Life Sciences,Alhavi Pharma( Iran),Validant (USA), Reva Cure,Almore Pharma, Unimark Remedies,Lorven Pharma,Titan Labs, Jubilant Generics,Morepen labs,Sidmak lab… etc.
Master of Science in Pharmaceutical Chemistry from BITS Pilani.
We are not only doing fault finding exercise. We are providing nonconformance, reference to guideline. Suggest Practical CAPA.
If any further support required for compliance, we can provide support by providing document templates/procedures.
During Gap identification audit, sufficient time is planned to discuss and explain about CAPA and expectation from regulators.
We provide end to end vendor evaluation support including auditing the vendor.
We provide support for different types of audits including computerized systems, data integrity, mock audits etc.
We provide audit report, We follow up with vendor for compliance action plan and ensure CAPA closure.
We will provide our expert auditor CV and CDA.
We follow the systematic approach so that the existing team will able to face similar types of audit independently.
We provide distant support also with no COST.
We are focusing on problem rather than theoretical guidance need. We have practical case studies and also ensure long term training effectiveness.
We provide training material, guidance and other supporting forms or templates.
We further ensure that, the practical training is come in to practice and being followed.
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