Frequently Asked Questions (FAQs) — Jalmex Pharma Consultancy

What services does Jalmex Pharma Consultancy offer?

Jalmex provides end-to-end pharmaceutical consultancy tailored to manufacturers, distributors, importers, and startups in Uganda. Core services typically include: • Regulatory Affairs & Product Registration: Preparation and submission of dossiers to the National Drug Authority (NDA), variations, renewals, and lifecycle management. • Good Manufacturing & Distribution Practices (GMP/GDP): Gap assessments, SOP development, training, and inspection readiness. • Quality Management Systems (QMS): Design, implementation, internal audits, and continuous improvement. • Pharmacovigilance (PV): Local PV contact person, adverse event reporting, risk management plans, and compliance with NDA/EAC requirements. • Market Access & Commercialization Strategy: Regulatory pathway advice, labeling/advertising review, and market-entry planning for Uganda and the EAC. • Pharmacy & Business Setup Support: Licensing guidance, premises inspection readiness, tax compliance, inventory management, and staff skilling. If you have a specific need (e.g., medical devices, cosmetics, or supplements), we can scope a tailored engagement.

Who are your typical clients?

We work with:

• Local and international pharmaceutical manufacturers seeking NDA registration or GMP support.

• Importers and distributors needing GDP compliance and supply-chain quality systems.

• Startups launching pharma/health product businesses in Uganda.

• Pharmacies and wholesale dealers preparing for licensing or inspections.

• Biotech, medical device, and supplement companies requiring regulatory and PV support in Uganda/EAC.

How do you support product registration with Uganda’s NDA?

We manage the full regulatory lifecycle, including:

• Pre-submission strategy: Choosing the right pathway (new, generic, variation, renewal) and compiling required documents.

• Dossier preparation: CTD-style documentation, quality/CMC, nonclinical/clinical summaries, labeling, and stability data alignment with NDA expectations.

• Submission & follow-up: Electronic/physical submissions, responding to queries, and coordinating with NDA until approval.

• Post-approval: Variations, renewals, and change-control advice to maintain compliance. We also advise on EAC harmonization where relevant for regional launches.

What are typical timelines for registration and inspections?

Timelines vary by product type, dossier quality, and NDA workload, but as a guide:

• New product registration (human medicines): Often several months from complete submission to decision; complex dossiers or queries can extend this.

• Variations/renewals: Generally faster than new registrations, but still subject to NDA review cycles.

• GMP/GDP inspections: Scheduling depends on NDA availability; we prepare you in advance to minimize findings and delays. We provide realistic timelines during scoping and keep you updated at each milestone.

Do you offer pharmacovigilance (PV) services?

Yes. Our PV support includes:

• Acting as local PV contact person for international companies.

• Setting up or strengthening PV systems, SOPs, and training.

• Adverse event case intake, processing, and reporting to NDA per local rules.

• Developing Risk Management Plans (RMPs) and reviewing promotional materials for safety compliance. This helps ensure ongoing compliance after product approval.

Can you help with GMP/GDP compliance and inspections?

Absolutely. We provide:

• Gap assessments against NDA/EAC GMP/GDP expectations.

• SOP development, staff training, and QMS integration.

• Mock inspections and corrective/preventive action (CAPA) planning.

• Premises suitability guidance for licensing of pharmacies and pharmaceutical businesses. Our goal is inspection readiness with sustainable quality systems.

Do you work with international companies entering Uganda?

Yes. We frequently support foreign manufacturers and distributors by:

• Providing local representation and a Ugandan contact for regulatory and PV matters.

• Advising on dossier localization, labeling, and NDA-specific requirements.

• Coordinating sample testing, stability commitments, and post-approval obligations. We align Uganda strategy with broader East African Community (EAC) plans where applicable.

What industries and product types do you cover?

Beyond human medicines, we support:

• Veterinary products

• Medical devices

• Cosmetics and personal care

• Food supplements and nutraceuticals Regulatory pathways differ by category; we map the correct route during onboarding.

How do you charge for your services?

We offer flexible commercial models depending on scope:

• Project-based fees (e.g., per dossier, per audit, per training).

• Retainer arrangements for ongoing regulatory/PV/QMS support.

• Bundled packages for startups (registration + QMS + training). We provide a written proposal with deliverables, timelines, and fees before starting work.

Where are you based, and do you work remotely?

Jalmex operates in Uganda (with Kampala as a key hub for pharma consultancy) and serves clients nationwide and across the EAC. We combine on-site visits (for audits, training, inspections) with remote collaboration for documentation and regulatory correspondence.

How do I get started?

1. Contact us with a brief description of your needs (product type, stage, targets).

2. We schedule a scoping call to clarify objectives, documents available, and timelines.

3. You receive a proposal with scope, milestones, and fees.

4. Upon approval, we begin onboarding and assign a dedicated consultant.