Proven Outcomes
Each case study represents a completed regulatory filing, a successful export clearance, or a market entry achieved on behalf of a client. Real outcomes, across markets around the world.
10+
Successful project outcomes
11
Countries reached
Antiretrovirals
Healglobal registered five antiretroviral brands with the Food and Drug Administration of Myanmar: Teneflamivir, Ritolop-H, Teniral, Tenolamivir, and Tricitenof. The registrations cover first-line, second-line, and combination ART regimens, positioning Healglobal as a direct brand-owner in the Myanmar HIV treatment market.
Ophthalmics
Supported an Indian manufacturer in preparing and submitting a sterile ophthalmic formulation dossier to NAFDAC. Scope included Q1 and Q2 sameness analysis against the reference listed drug, biowaiver positioning under ICH Zone IVb conditions, stability documentation, and the full ACTD compilation.
Hormonal Therapy
Preparing the regulatory submission for a hormonal capsule formulation to the Algerian Ministry of Health. Engagement includes country-specific dossier formatting, sourcing of supporting clinical references, and coordination with the manufacturing partner on stability documentation.
Topical Formulations
Regulatory pathway design and dossier preparation for a topical formulation targeting the UAE market under the Ministry of Health and Prevention. Includes coordination with a UAE-based local agent for submission and post-registration commercial pathway.
Oncology
Active regulatory engagement to register an oncology product with the Centre for Examinations and Tests in Health Service, Belarus. Scope covers full CTD dossier preparation, GMP certification reconciliation, and language-localised documentation.
Oncology
Regulatory support for an oncology product registration with FDA Philippines, including ACTD dossier preparation, bioequivalence positioning, and coordination with a Philippine-based marketing authorisation holder.
Antibiotics, IV Fluids & Critical Care
Coordinated supply for a multi-product tender bid covering oral antibiotics, IV fluids, hospital injectables, and critical care formulations for a Tanzanian regional distributor. All products sourced from WHO-GMP-approved manufacturing partners with full export documentation.
Antimalarials
Supporting an Indian antimalarial manufacturer in entering Côte d'Ivoire and Senegal. Scope spans regulatory pathway design, French-language dossier preparation, local agent identification, and registration coordination across both markets in parallel.
Chronic Care (NCDs)
Sourced a portfolio of chronic care formulations for a Vietnamese regional importer, including metformin, glimepiride, amlodipine, telmisartan, and losartan. All products sourced from PIC/s-approved Indian manufacturers with stability documentation and Certificate of Pharmaceutical Product.
Antibiotics
Dossier preparation and submission support for an Indian antibiotic manufacturer entering the Uzbek market. Engagement covered State Center for Expertise and Standardization requirements, Russian-language documentation coordination, and local partner identification.
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