Welcome to Zexa Consultants
Focused Pharma Engineering and GLP Solutions
Zexa Healthcare Consultants is comprises of highly skilled team of professionals having exposure of more than three decades of industrial experience in projects, engineering operations, and quality and regulatory affairs. Our subject matter experts (SMEs) will provide the best knowledge on latest technology and suggest the best solutions mainly to the major concerns. Our dealing is based on dynamic and innovative approach to provide solutions to our clients in Pharmaceutical and Healthcare, Bulk and API, Personal care, Foods, and Beverages. Consultants surely will add valuable solutions to clients to put up state of art facilities satisfying their needs, optimizing their resources and getting a competitive edge.
Founders Profile:
Dr R. A. Singh He is having more than 40 years practical experience in analytical chemistry and commercial testing laboratory in both private as well as Government sector, you are rest assured that the consultancy services offered are value for money.
Qualification:
Ph.D., AIC, FIC, CC
Position Held:
Director – Regional Drugs Testing Laboratory, Chandigarh,
Central Drugs Standard control Organization,
Ministry of Health and Family Welfare,
Government of India.
Director Technical – Arbro Pharmaceutical Pvt .Ltd.,
Laboratory GAP analysis
Laboratory design and development
Laboratory upgradation as per GLP requirement
NABL Accreditation as per ISO 17025
Training to technical staff
Legal advice for (not of standard quality) NSQ samples
Legal reply of Government letters
Sampling and analysis of drugs, cosmetics, food etc samples
QA/ QC audits
Regulatory compliance
WHO GMP and GLP CERTIFICATION preparation
SOP PREPARATION
Project Management
- Strategic project planning
- Project management office set-up and support
- Project monitoring services
- Cost management
- Bid management
- Contract management
- Project supply chain management
- Risk management
Quality Management Service
- Provide technical guidance to design, prepare & implement Quality Management system for Drug Products (SVP, LVP, OSD & Liquid Orals, Cream & Ointments), API’s, Food & Beverages, Cosmetics & Ayurvedic facilities..
- Qualifications & Validation Support
- Facility
- Equipment
- HVAC System
- Water generation and distribution System
- Compressed Air & Nitrogen System
- Heat Mapping Studies
- Documentations support as per regulatory requirement
- SOP’s
- Equipment qualification URS, DQ,IQ,OQ, PQ
- GMP/GLP trainings
- GMP audits, gap analysis and compliance support, key risk and mitigation
Operational Excellence
- Plant capacity enhancement
- Improvement in Plant operational efficiencies
- Resource optimization
- Equipment
- Energy audits and conservation measures
- Yield improvement
- End of line automation
Expertise
- Expertise in conducting audits and gap assessment of Quality Control, Microbiology, Quality System.
- Verification of CAPA’s efficiency .
- Training on Data Integrity, GMP/GDP/GLP/Computer System Validations ,Quality
- Risk Management, Good Microbiological Practices
- Remediation and Regulatory compliance.
- Assessment of Data Integrity related issues in Laboratory System.
- Technology Transfer and Analytical Method Validations
- Involved in conducting Risk Assessment for Products, Processes and Environment
- Monitoring Program.
- Audits -Vendor Qualification Program, Third Party and Due diligence Audits.
- Computer System Validations of QC and Micro System.
- Reviewing of Investigations related to OOS, Deviations, Incidents, Microbial Data Deviations ,OOC, OOT.
- Improving the productivity of QC labs by streamlining processes through end to end mapping,
- Qualifications ,Validations, Method Development
- Change Management System
Water plant setup consultancy
- Research the regulatory requirements and permits necessary for operating a water plant in your area.
- Identify and secure a reliable water source, such as groundwater or surface water.
- Consider incorporating monitoring and control systems to ensure consistent water quality.
- Consider factors like energy efficiency, scalability, and maintenance requirements when selecting equipment.
- Adhere to local regulations and obtain the necessary permits and licenses.
- Recruit qualified personnel with expertise in water treatment operations and maintenance.
- Establish protocols for addressing any deviations from desired water quality standards.
- Develop a business plan, including a detailed financial analysis, market research, and marketing strategies.
Gold testing laboratory consultancy
- Regulatory Requirements
- Laboratory Design and Infrastructure
- Equipment and Instruments:
- Testing Procedures and Methodologies
- Staffing and Expertise:
- Quality Control and Assurance
- Safety Measures
- Data Management and Reporting
- Accreditation and Certification
- Marketing and Client Acquisition