Our Offerings
Pharmaceuticals: Tablets, capsules, syrups, injections, ointments, nutraceuticals & more.
Regulatory Services:
Dossier compilation & CTD/ACTD submissions (ASEAN, CIS, AFRICA, GCC, ROW)
DMF (Open & Closed Part) preparation
BA/BE studies & clinical trials
Analytical method validation (HPLC, UV, dissolution, impurities, solvents)
Comparative Dissolution Profiles (with chromatograms & spectra)
Bioanalytical validation & ANOVA reporting
SmPC, PIL, PSUR, RMP, PSMF & PV system SOPs
Embassy legalization & CDSCO submissions
Why Partner With Us
✔ Certified Quality – WHO-GMP manufacturing
✔ Wide Product Portfolio – high-demand medicines across therapeutic areas
✔ Competitive Pricing – strong margins for partners
✔ Reliable Supply & Logistics – fast global delivery
✔ Regulatory & Marketing Support – dossiers, training, brochures, promotional tools
Regulatory Services
Comprehensive support for pharmaceutical regulatory compliance.
Dossier Compilation
Expertise in CTD and country-specific submissions.
Clinical Trials
Conducting BA/BE studies for effective drug evaluation.
Frequently Asked Questions
What services do you offer?
We offer regulatory services, dossier compilation, and analytical method validation for pharmaceutical products.
What is dossier compilation?
Dossier compilation involves preparing CTD, ACTD, and country-specific submissions for various international markets.
What are BA/BE studies?
BA/BE studies are bioavailability and bioequivalence studies essential for drug approval and market entry in various regions.
How do you ensure quality?
We validate analytical methods and conduct rigorous testing.
What is DMF?
DMF stands for Drug Master File, which includes detailed information about drug substances and manufacturing processes.
Pharmaceuticals
Quality medicines for your business growth.
Services
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