Our Services
We provide comprehensive regulatory and compliance solutions designed to reduce risk, accelerate approvals, and support sustainable market access.
Regulatory Affairs
What We Do
- Product registration and renewals
- Dossier preparation and submission
- Regulatory strategy and gap assessments
- Authority liaison and follow-ups
Business Value
✔ Faster time to market
✔ Reduced risk of rejection or delays
✔ Clear regulatory roadmap for your products
✔ Reduced risk of rejection or delays
✔ Clear regulatory roadmap for your products
Pharmacovigilance & Vigilance
What We Do
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Establishment of pharmacovigilance systems
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Adverse event reporting and management
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Periodic safety update reports (PSURs)
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Risk management planning
Business Value
✔ Compliance with post-marketing obligations
✔ Reduced legal and regulatory risk
✔ Improved product safety monitoring
✔ Reduced legal and regulatory risk
✔ Improved product safety monitoring
Storage & Distribution Compliance
What We Do
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GSDP / GDP compliance audits
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SOP development and implementation
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Warehouse and distribution assessments
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Training for staff and quality teams
Business Value
✔ Avoid penalties and license suspension
✔ Maintain product quality and integrity
✔ Pass regulatory inspections with confidence
✔ Maintain product quality and integrity
✔ Pass regulatory inspections with confidence
Why Choose Alcare Consultancy?
✔ Deep understanding of local regulatory frameworks
✔ Hands-on experience with regulatory submissions
✔ Clear communication with authorities
✔ Practical, business-focused advice