MiDeRo Pharma & FMCG Consultants
Prevent Mishaps Proactively
WHO WE ARE
A seasoned cGMP Auditor and Consultant with over three decades of experience in Pharmaceutical, biotech, food, and cosmetic industries. Specializing in microbial risk mitigation, plant-wide contamination control, and regulatory compliance, this expert bridges the gap between theoretical microbiology and practical manufacturing realities.
Known for a meticulous approach to microbial robustness assessments, utility system evaluations, and sanitation strategy design.
WHAT WE OFFER
- GMP Compliance & Audit Readiness: WHO, USFDA, MHRA, EU-GMP standards
- Microbial Risk Assessment: Identification of contamination hotspots across equipment, utilities, and processes
- Sanitation Program Design: Development of robust cleaning and disinfection protocols tailored to product and facility type
- Water System Evaluation: Microbial control strategies for purified water, WFI, and utility loops
- Validation Expertise: Cleaning, process, and equipment validation with microbial control focus
- CAPA & Change Control: Root cause analysis and remediation planning for microbial excursions
- Training & Mentorship: Conduct workshops on microbial awareness, aseptic practices, and GMP fundamentals
- QMS: auditing of whole QMS as per cGMP, Q7A, revised Schedule M. Well versed with eQMS systems like Veeva, BQ and trackwise.
- Microbial Design Robustness Focus
- Whole Plant Microbial Mapping: From raw material intake to packaging, identifying microbial ingress points
- Preservative & Process Heat Misconceptions: Educating teams on limitations of formulation- and process-based microbial controls.
- Environmental Monitoring Strategy: Designing EM programs that go beyond compliance to predictive control
- Biofilm Risk Management: Detection and remediation strategies for high-risk zones in water and air systems
- Formula Assessment: Assessment of formula based on the water activity and type of preservatives.
Why MiDeRo Consultancy ?
Our Founder and CEO Balvant Joshi is a Global QA leader with three decades of experience in leading Global Pharma, FMCG, Medical, OTC, and Personal care product industry having proven track record of value creation through microbial design robustness assessments and end to end Quality for supply network.
He is a Pharmacist from UDCT (ICT) Mumbai and with his experience in conducting more than 100 GMP audits and 50 + microbial design robustness assessments he has founded this consultancy.
Some of the notable achievements of his journey are –
- Results-driven QA & Compliance Leader with robust expertise of 30+ years, driving excellence in Pharmaceutical and Consumer sectors.
- Managing quality activities across diverse regions, including Asia, Middle East, and Africa.
- Developed and deployed Purified Water generation and distribution system, which was accepted globally as gold standard.
- Designed and executed liquid manufacturing facility in 11 months.
- Led multicultural quality teams in Asia pacific, middle east and Africa.
- Traveled extensively in the whole APAC region for audits, start up and technological transfers.
- Investigated and identified correct root causes for complex failures/contamination issues in manufacturing plants Globally.
Contact Us
Bungalow No 15 A Dnyaneshwar Nagar CHS Regency Estate Kalyan Shil Road, Dombivali east District Thane 421203. contact@midero.in, balvantdj@gmail.com. Phone -+91 9167331012 Linkedin Page – www.linkedin.com/in/balvant-joshi