Regulatory Compliance
Committed to the highest standards of pharmaceutical manufacturing and quality assurance
At Health Berry Lifesciences Pvt. Ltd., compliance is not just a regulatory requirement—it's the foundation of our commitment to delivering safe, effective, and high-quality pharmaceutical products. We adhere to stringent national and international standards to ensure that every product meets the highest benchmarks of quality and safety.
Our Certifications
Recognized by leading regulatory bodies worldwide
WHO-GMP Certified
Certified by the World Health Organization for Good Manufacturing Practices, ensuring international quality standards in pharmaceutical production.
Scope: Pharmaceutical Manufacturing
Standard: WHO Technical Report Series
ISO 9001:2015
International Organization for Standardization certification for Quality Management Systems, demonstrating our commitment to consistent quality and continuous improvement.
Scope: Quality Management
Standard: ISO 9001:2015
GMP Certified
Good Manufacturing Practice certification ensuring that pharmaceutical products are consistently produced and controlled according to quality standards.
Scope: Manufacturing Operations
Authority: Central Drugs Standard Control Organization (CDSCO)
FSSAI Approved
Food Safety and Standards Authority of India approval for nutraceutical and health supplement products, ensuring safety and quality in food-grade formulations.
Scope: Nutraceuticals & Supplements
Authority: FSSAI, Government of India
Drug Manufacturing License
Licensed by the State Drug Authority for manufacturing pharmaceutical formulations under Schedule M compliance.
License Type: Form 25 & Form 28
Authority: FDA Maharashtra
Export Authorization
Authorized for pharmaceutical exports to international markets, complying with destination country regulations and WHO standards.
Scope: International Trade
Markets: ASEAN, MENA, Africa
Regulatory Framework
Compliance with comprehensive pharmaceutical regulations
Indian Pharmaceutical Laws
Drugs and Cosmetics Act, 1940
Regulation of import, manufacture, distribution, and sale of drugs and cosmetics
Drugs and Cosmetics Rules, 1945
Implementation guidelines and operational procedures for pharmaceutical activities
Schedule M (GMP Requirements)
Good manufacturing practices for pharmaceutical products
Pharmacy Act, 1948
Regulation of pharmaceutical practice and profession
Narcotic Drugs and Psychotropic Substances Act, 1985
Control and regulation of controlled substances
International Standards
WHO Good Manufacturing Practices
Global standards for pharmaceutical manufacturing quality
ISO 9001:2015 QMS
Quality management system requirements and continuous improvement
ICH Guidelines
International Council for Harmonisation of Technical Requirements
Pharmacopeial Standards
Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP)
Quality Assurance Practices
Manufacturing Controls
- ✓Raw material testing and qualification
- ✓In-process quality control checks
- ✓Finished product testing and release
- ✓Equipment calibration and validation
- ✓Environmental monitoring and control
Documentation & Traceability
- ✓Batch manufacturing records
- ✓Standard Operating Procedures (SOPs)
- ✓Change control management
- ✓Deviation and CAPA systems
- ✓Product complaint handling
Personnel Training
- ✓GMP training programs
- ✓Job-specific skill development
- ✓Hygiene and safety protocols
- ✓Regular competency assessments
Audits & Inspections
- ✓Regular internal quality audits
- ✓Regulatory inspection readiness
- ✓Vendor qualification audits
- ✓Third-party certification audits
Pharmacovigilance & Safety Monitoring
We maintain a robust pharmacovigilance system to monitor the safety of our products throughout their lifecycle. Our commitment includes:
Adverse Event Reporting
Systematic collection and evaluation of adverse drug reactions
Post-Marketing Surveillance
Continuous monitoring of product safety in real-world use
Risk Management
Proactive identification and mitigation of potential risks
Regulatory Reporting
Timely submission of safety data to regulatory authorities
Environmental & Safety Compliance
Environmental Management
Committed to sustainable pharmaceutical manufacturing with minimal environmental impact:
- ✓Effluent treatment and waste management systems
- ✓Energy conservation and resource optimization
- ✓Compliance with Environmental Protection Act, 1986
- ✓Green chemistry initiatives
Occupational Health & Safety
Ensuring a safe working environment for all employees:
- ✓Compliance with Factories Act, 1948
- ✓Occupational Safety and Health Administration (OSHA) standards
- ✓Personal protective equipment (PPE) protocols
- ✓Emergency response and fire safety systems
Our Commitment
At Health Berry Lifesciences, regulatory compliance is embedded in our organizational culture. We continuously invest in infrastructure, training, and systems to maintain the highest standards of pharmaceutical manufacturing. Our goal is to not only meet but exceed regulatory expectations, ensuring that every product we manufacture is safe, effective, and of the highest quality.
For regulatory inquiries or compliance documentation, please contact our Regulatory Affairs Department.
Contact Regulatory Affairs
For questions about our regulatory compliance, certifications, or quality standards, please reach out to our Regulatory Affairs team:
Health Berry Lifesciences Pvt. Ltd.
Regulatory Affairs & Quality Assurance Department
Office No.2, S. No 40/2, Near Sinhgad College
Kondhawa Budruk, Pune, Maharashtra 411048
Email: regulatory@healthberrylifesciences.com
Quality Assurance: qa@healthberrylifesciences.com
Phone: +91 99605 60515