Trusted Pharma Export & Regulatory Services

Affordable, High-Quality Medicines for Your Business Growth

Trusted by Many

★★★★★

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About Us

KaviSar International Pharma is a global Merchant Exporter and Regulatory Consultancy based in India, committed to making high-quality, affordable healthcare accessible across the world. We bridge the gap between WHO-GMP compliant manufacturers and international markets, ensuring a seamless flow of pharmaceutical products and regulatory services.

With our extensive expertise, we provide end-to-end solutions—from sourcing medicines and developing product dossiers to handling global regulatory submissions and export documentation.

Who We Are

KaviSar International Pharma was founded with a vision to become a trusted healthcare partner for pharmaceutical distributors, importers, and healthcare institutions worldwide. Our name is inspired by values of care, trust, and global collaboration, and we operate with the goal of improving patient well-being across emerging and developing nations.

Delivering Quality Pharmaceuticals Across Borders

Merchant Exporter & Regulatory Consultancy

KaviSar International Pharma is a trusted name in the pharmaceutical industry, delivering WHO–GMP certified formulations that meet the highest international standards of quality, safety, and efficacy.

We operate as a manufacturer, merchant exporter, wholesale distributor, and regulatory consultancy partner, providing a wide range of affordable, high-quality medicines along with end-to-end regulatory solutions to support global market access.

Our mission is to empower partners with cost-effective pharmaceutical products and professional DRA (Drug Regulatory Affairs) services, helping them meet market demand and maximize growth.

Why Partner with KaviSar International Pharma?

1. Certified Quality

All products are manufactured in WHO–GMP certified facilities, ensuring compliance with global regulatory standards.

2. Extensive Product Portfolio

  • Wide range of formulations, including:

    • Tablets (antibiotics, antihypertensives, pain relief, etc.)

    • Capsules (nutraceuticals, anti-inflammatory, etc.)

    • Syrups (pediatric, multivitamins, cough & cold)

    • Injections, ointments, and more

3. IHS Specifications & Regulatory Documentation

  • Formulations aligned with IHS specifications and supported with complete regulatory documentation for seamless international registration.

4. Competitive Pricing

  • Market-driven pricing ensures strong profit margins without compromising on quality.

5. Reliable Supply & Logistics

  • Fast and reliable delivery with consistent availability, global logistics support, and excellent after-sales service.

6. Sales & Marketing Support

  • Assistance with product training, brochures, promotional material, and market strategies to strengthen partner sales efforts.

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Regulatory Services

Along side product supply, we provide comprehensive Regulatory Affairs services for global submissions and compliance.

  • Dossier Compilation & Submission

    • Preparation of CTD, ACTD, and country/region-specific dossiers for ASEAN, CIS, AFRICA, GCC, and ROW markets.

  • CTD Dossier Writing

    • End-to-end authoring and formatting of regulatory dossiers.

  • Drug Master File (DMF)

    • Compilation of Open Part and Closed Part for regulatory agencies.

  • BA/BE Studies & Clinical Trials

    • Design, conduct, and reporting of Bioavailability/Bioequivalence studies and clinical documentation.

  • Analytical Method Validation

    • Validation of methods for Dissolution, Assay, Related Substances (Impurities), and Residual Solvents
      (HPLC with chromatograms, UV with spectra).

  • Comparative Dissolution Profile (CDP)

    • CDP reports supported with HPLC chromatograms and UV spectra.

  • Bioanalytical Validation & Reports

    • Protocol preparation, validation reports, and ANOVA statistical analysis for BA/BE studies.

  • Product Information Updates

    • Drafting and updating SmPC (Summary of Product Characteristics) and PIL (Patient Information Leaflets).

  • Pharmacovigilance Services

    • PSUR (Patient Safety Update Reports)

    • RMP (Risk Management Plans)

    • PSMF (Pharmacovigilance System Master File)

    • SOP development for pharmacovigilance & surveillance activities

  • Legalization & Document Services

    • Embassy & Apostille legalization

    • Submission & collection of documents with CDSCO (Neutral Code applications)

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Expanding Healthcare Access Worldwide

Global Export Projects

We have successfully executed pharmaceutical export projects across Asia, Africa, and the Middle East. Our partnerships with distributors, wholesalers, and healthcare institutions ensure that high-quality medicines reach patients in both regulated and semi-regulated markets.

Regulatory Consultancy Projects

Our team has supported multiple companies in preparing CTD/ACTD dossiers, Drug Master Files (DMFs), and regulatory submissions for approvals across GCC, ASEAN, CIS, and African countries. These projects demonstrate our expertise in navigating diverse global regulatory frameworks.

Product Development Projects

We continuously develop and customize formulations such as antibiotics, analgesics, and cardiovascular medicines to meet the unique requirements of different markets. From comparative dissolution studies to analytical method validation, our projects are designed to ensure efficacy, safety, and compliance.

Healthcare Access Projects

Through collaborations with local partners, KaviSar International Pharma contributes to expanding affordable healthcare access in underserved regions. Our ongoing projects focus on supplying essential medicines at competitive prices to improve patient outcomes.

Future Projects

We are actively exploring new opportunities in biologics, specialty formulations, and nutraceuticals, as well as joint ventures with regional partners to strengthen our presence in emerging markets.

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