Ensuring Global Standards, Safety & Market Readiness
At Leobery Pharmaceutical Industries LLC, regulatory excellence is at the core of our operations. Our Regulatory Affairs & Compliance division ensures that every product meets the legal, scientific, and quality standards required by authorities across international markets.
We work proactively with global agencies to ensure our medicines remain safe, effective, compliant, and readily available to patients worldwide.
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🔹 Our Regulatory Expertise
We support full-spectrum regulatory activities across multiple product categories:
• Prescription medicines (Rx)
• Over-the-counter (OTC) products
• Pediatric formulations
• Nutritional supplements (vitamins, minerals)
• Export-only formulations
• Contract manufacturing & private label dossiers
Our team is experienced in handling regulations across India, USA, EU, Middle East, Africa, and Asia-Pacific regions.
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🔹 Global Regulatory Frameworks We Follow
Our regulatory submissions and quality systems align with:
• WHO-GMP Guidelines
• CDSCO (India) Requirements
• US FDA cGMP (21 CFR Parts 210 & 211)
• EMA (European Medicines Agency) Standards
• ICH Q1–Q10 Guidelines
• GCC & ASEAN Regulatory Guidelines
• ISO 9001:2015
Compliance is maintained from product development to post-marketing.
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🔹 Regulatory Services We Provide
✔ 1. Dossier Preparation & Submission (CTD / eCTD)
We prepare complete regulatory dossiers required for global product registration:
• CTD Modules 1–5
• eCTD compilation
• Quality summaries (QOS, SMF)
• Pharmaceutical development reports (PDR)
• Validation & stability data
• Labeling & artwork compliance
Our dossiers are tailored for the requirements of each country.
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✔ 2. Product Registration & Lifecycle Management
Our regulatory team handles:
• New product registration
• Renewal of registrations
• Variations, amendments and line extensions
• Change control management
• Country-specific updates
• Import/Export licensing support
We support partners throughout the complete product lifecycle.
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✔ 3. Labeling, Artwork & Packaging Compliance
We ensure your products meet regional labeling rules:
• Ingredient declarations
• Drug facts & nutritional info
• Warning statements
• Storage conditions
• Track-and-trace requirements
• QR code & serialization
• Child-safe packaging where required
All artworks follow local language and regulatory font/format standards.
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✔ 4. Regulatory Intelligence & Market Access
Our team continuously monitors:
• Policy changes
• Regional guidelines
• Pharmacopoeial updates (IP/USP/BP/EP)
• New regulatory frameworks
• Import restrictions & new trade regulations
We provide insights to ensure smooth entry into new markets.
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✔ 5. Pharmacovigilance & Post-Marketing Surveillance
Patient safety is our ongoing responsibility.
Our safety monitoring includes:
• Adverse Drug Reaction (ADR) reporting
• Medical & scientific evaluation
• Risk-benefit assessment
• Quarterly/annual PSUR/DSUR reports
• Product quality complaint handling
• Field safety actions & recalls (if ever required)
A dedicated Pharmacovigilance (PV) team ensures compliance with local & global safety reporting requirements.
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✔ 6. GMP Audits & Vendor Qualification
To maintain global compliance:
• Internal GMP audits
• Third-party audits
• Vendor & API supplier qualification
• Periodic factory inspections
• CAPA implementation
All manufacturing partners undergo strict qualification and monitoring.
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🔹 Why Regulatory Compliance Matters
For Leobery, compliance ensures:
• Patient safety
• Product reliability
• Market acceptance
• Protection from regulatory delays
• Global credibility & brand trust
We work with a zero-compromise approach to ensure products meet the highest regulatory standards.
