ESTEEM PHARMA
LIMITED
Bridging Regulation and Access to Quality Assured Health Products
Zambia’s specialist regulatory consultancy for pharmaceutical, veterinary, and allied substance registration, facility licensing, and compliance support — incorporated 2021.
Company Overview
Zambian-Registered Pharmaceutical Regulatory Consultancy
About Esteem Pharma Limited
Esteem Pharma Limited is a Zambian-registered private limited company incorporated on 17th August 2021 under the Patents and Companies Registration Agency (PACRA). The company provides regulatory consultancy services across the pharmaceutical and veterinary sectors, covering dossier preparation, marketing authorization, and compliance support.
We bridge the gap between manufacturers, marketing authorization holders (MAHs), and the National Health Regulatory Authority (ZAMRA) — ensuring safe, effective, and quality-assured health products reach the Zambian market efficiently and compliantly.
17th August 2021 (PACRA)
120210019364
2295093752
Retail Pharmacy
Dossier Prep
Veterinary
Manufacturing
Our Services
Comprehensive Regulatory Consultancy Solutions
Regulatory Consultancy
The core of our practice — advising clients and bridging the gap between business and regulatory authorities.
- Advising on regulatory requirements
- Guiding compliance with national laws
- Acting as bridge between clients & ZAMRA
Product Registration & Market Authorization
End-to-end registration for human medicines, veterinary products, vaccines, IVDs, and allied substances.
- Human & veterinary medicines
- Vaccines & IVD products
- Allied substances registration
- ZAMRA follow-up & liaison
Dossier Preparation & Documentation
The technical backbone of our consultancy — compiling and formatting complete regulatory submissions to ZAMRA standards.
- Compiling regulatory dossiers
- Technical document review
- Formatting to ZAMRA standards
Compliance & Quality Systems
Keeping clients compliant post-registration through robust quality infrastructure and audit readiness.
- SOP development & review
- GDP & GSP advisory support
- Audit & inspection preparation
Facility Licensing Support
Guiding clients setting up wholesale or retail pharmacy operations through all licensing requirements.
- Wholesale pharmacy registration
- Retail pharmacy registration
- Facility regulatory compliance
Pharmacovigilance & Post-Market Support
Monitoring product safety and quality after market authorization as an ongoing regulatory responsibility.
- Setting up PV systems
- Product quality complaint handling
- Post-marketing surveillance
Client Engagement & Representation
Acting as your official in-country representative and managing all communication with ZAMRA on your behalf.
- Local Responsible Person (LRP)
- Communicating with ZAMRA
- Providing regulatory updates
Training & Capacity Building
Empowering your teams with the knowledge and skills to maintain ongoing regulatory and quality compliance.
- Regulatory compliance training
- Quality systems training
- Pharmacovigilance training
Why Choose Us
Your Strategic Regulatory Partner in Zambia
Our team's direct involvement in Zambia's national regulatory frameworks gives clients an unmatched advantage in navigating the ZAMRA approval process.
Regulatory Expertise
Managed by professionals actively involved in developing Zambia's national regulatory frameworks.
Comprehensive Coverage
Services spanning human, animal, and allied substances across the full product spectrum.
End-to-End Efficiency
Full dossier lifecycle support from initial brief to marketing authorization.
Strategic Partnerships
Trusted by local and international manufacturers, distributors, and MAHs.
Proven Compliance Record
Successful product registrations and audits across multiple therapeutic categories.
Registration Process
How We Get Your Products to Market
Initial Brief & Scoping
Understand your products, target markets, and regulatory requirements.
Dossier Compilation
Professional preparation of complete regulatory dossiers and technical documentation.
Regulatory Submission
Accurate, compliant submission to the National Health Regulatory Authority (ZAMRA).
ZAMRA Review & Liaison
Active liaison with ZAMRA reviewers to address queries and expedite the process.
Marketing Authorization
Receipt of approval and ongoing post-authorization regulatory support.
Pharmacovigilance
Continuous post-market safety monitoring, adverse event reporting, and product quality surveillance.
Engagement & Pricing
Consultancy Fee Structure (USD)
Human Medicines
Full regulatory dossier preparation and submission for human pharmaceutical products.
Enquire NowAnimal Health Medicines
Complete veterinary medicine registration from dossier compilation to ZAMRA submission.
Enquire NowAllied Substances
Registration support for allied substances under the Medicines and Allied Substances Act No. 3 of 2013.
Enquire NowLocal Responsible Person
Monthly retainer as your designated LRP for ongoing regulatory compliance representation in Zambia.
Enquire NowPrices exclude statutory fees payable to regulatory authorities (ZAMRA and other bodies).
Leadership Team
The Professionals Behind Esteem Pharma
Contact Us
Ready to Register Your Product? Let’s Talk.
Physical Address
Plot 12546/M, Lilayi Road, Lusaka, Zambia
Managing Director
+260 977 814934
Director of Operations
+260 973 172281
info@esteempharma.com
Documents Available Upon Request
The following verified documents are available for due diligence or partnership purposes.
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