Quality & Regulatory
To get your product in the market quickly and efficiently, you need to have sound Quality and Regulatory strategy. With Maxval, thanks to the abundant industry experience of our experts, your Quality and Regulatory policy is in safe hands.
We provide customized, value-added solutions, processes and enhanced quality standards to optimize business efficiencies and minimize regulatory risk.
Our Domain Expert’s critical review of your quality systems and regulatory compliance measures will make your facility “Any-Time Ready” for approvals by global regulatory agencies in a sustainable manner
- Remediation of Inspectional observations, CAPA beneficiary of your Management and effectiveness verification
- Quality Culture build-up & training management
- Extensive interaction with regulators and a good insight of expectations of regulators
- Transparency and robustness of QMS Systems
- High credibility of Maxval experts in the external world, wide recognition and acceptability of us by customers
- Practical SOP Development
- QMS design development and implementation
- Practical BMR design
- Documentation design, distribution, archival and retrieval
- Developing periodic Internal Audit Systems for ‘Any Time Inspection Readiness’
- Effective review management of day to-day documentation – Manufacturing, Lab, QA, Warehouse and Engineering systems
- Training of employees for handling External Regulatory inspections
Practical SOP Development,
QMS Design Development and Implementation
Practical BMR Design
Documentation Design, Distribution, Archival and Retrieval
Developing periodic Internal Audit System for ‘Any Time Inspection Readiness
Effective review management of day to-day documentation – Mfg, Lab, QA, WH, Engineering Systems
Training of employees for handling External Regulatory Inspections
KARKUN ANAND (K. ANAND) – Quality and Regulatory Domain Expert
Karkun Anand is the Founder and CEO of Qualiminds Corporate Services Pvt Ltd, a Mumbai based Pharma Consulting company in India. He provides leadership, direction and management of Qualiminds consulting operations in India. He founded Qualiminds after a 35-year career in the Pharmaceutical (APIs and Finished Dosages of all kinds), and Biologics drug product manufacturing companies, where he held leadership position in Quality and Regulatory management. He held lead responsibility for Quality, GxP Compliance, Regulatory Affairs, Technology Transfer and Technical Operations functions of APIs, Finished dosages – Oral and Injectables, Medical Devices and Biologics manufacturing companies in India. He was responsible for building quality systems, instituting QbD approaches in R&D and in Manufacturing, providing strategies in regulatory management, building quality culture across the organization, and providing oversight strategies for sustainable compliance
EXPERTISE
- Team building for sustainable quality culture and quality compliance procedures
- Led teams in preparing for Regulatory inpsetcions of facilities manufacturing APIs, Dosage forms (Oral, Complex, Injectables) – US FDA, MHRA, TPD, TGA, EU from initial stages to sustainable compliance culture build up
- Resolution of compliance issues – Regulatory Findings and Enforcement Actions
- Participated in face to face meetings with US FDA and WHO senior officials to satisfactorily resolve regulatory concerns leading to site/product approvals
- Resolution of Quality, GxP Compliance in Microbiology and Sterility Assurance
- Audit Cell Development laboratory, compliance related to scale up of Molecular Anti-bodies, characterization and quality assessment of mAbs
- Provide guidance to R&D teams in developing understanding on QbD, Scale up and Technology transfer, and Life cycle management of pharmaceutical products meeting compliance and quality in all GxP areas
- Establishment of Quality Function and Quality Leadership Development program
- Data Integrity management policies, automation for audit trails and minimising human errors
- Oversee and manage regulatory inspections for companies
- Global Quality Systems strategies
EXPERIENCE
- Executive Vice President & Global Head of Quality and Regulatory Affairs at Dr. Reddy’s Laboratories Ltd, Hyderabad in India, which included Biologics facilities
- President & Global Head of Quality and Regulatory Affairs at Cadila Healthcare (Zydus) Ltd, Ahmedabad in India, which included Biologics Quality operations
- Chief Operating Officer at Famy Care Ltd (now Mylan), Mumbai in India for their Oral and Sterile contraceptive operations in India
- President and Global Head of Quality and Regulatory Affairs at Glenmark Pharmaceuticals Ltd , Mumbai in India. Quality operations included APIs, Drug products, NCE program, NBE program, managing due diligence for out-licensed partners for Discovery program besides managing entire Generic quality operations
- Vice President and Global Head of Quality at Lupin Limited, Mumbai in India. Quality operations related to APIs, Finished dosages – OSD and parenteral products, Biologics development program, medical diagnostics
EDUCATION
- Master of Science in Analytical Chemistry, University of Mumbai
PROFESSIONAL AFFILIATIONS
- Member of the Board – Parental Drug Association (PDA) of India Chapter
- Member of Indian Pharmaceutical Association (IPA)
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