Welcome to AAHVI Pharma
Expert Regulatory & Licensing Support for the Pharma Industry
From regulatory approvals and licensing to dossier submissions and import registrations, AAHVI PHARMA simplifies every step of your pharmaceutical compliance journey — reliably, efficiently, and end-to-end.
ABOUT AAHVI PHARMA
Your Trusted Partner in Pharma Compliance & Licensing
AAHVI PHARMA PVT. LTD. is a Hyderabad-based pharmaceutical consultancy and distribution company, specializing in end-to-end regulatory, licensing, and compliance services for the pharmaceutical industry. From R&D site approvals, dossier preparation, and manufacturing licenses to import/export registration and product compliance, we serve as a strategic partner for pharmaceutical companies navigating India’s complex regulatory ecosystem. With hands-on experience across APIs, formulations, and clinical research segments, we align operations with the latest requirements under the Drugs & Cosmetics Act, NDCT Rules, and CDSCO/DCGI frameworks.
What We Provide
At AAHVI PHARMA PVT. LTD., we offer a complete range of regulatory and compliance services tailored for pharmaceutical companies, R&D sites, importers, and distributors. Our goal is to help you navigate the complex regulatory landscape with confidence, speed, and accuracy.
Regulatory & Statutory Compliance
We ensure your business is fully aligned with Indian pharmaceutical laws and guidelines. Our team assists with DCA, CDSCO, and DCGI submissions, test licenses, NDCT rule compliance, GMP/GLP certifications, and more.
Licensing & Approvals
From manufacturing to retail and wholesale, we manage all types of drug license applications and amendments. This includes Forms 24, 25, 27, 28, 25B, and specialized licenses like Schedule X, NDPS, repacking, and loan licenses.
Import & Product Registration
We handle the complete process of product registration and import licensing for APIs and formulations. Our support includes dossier preparation, eCTD submissions, and securing CoPP, WHO-GMP, and Free Sale Certificates.
Pharma Distribution Services
AAHVI also distributes a wide range of pharmaceutical products to hospitals, clinics, and medical stores. Our catalog includes critical care, paediatric, ophthalmic, injectable, and nutraceutical formulations.
eCTD Preparation & Submission Services
We prepare and submit eCTDs for INDs, NDAs, ANDAs, and DMFs in full compliance with global regulatory standards including US FDA, EMA, Health Canada, TGA, and MHLW.
Why Choose AAHVI?
With years of experience in pharmaceutical compliance and government liaison, AAHVI PHARMA delivers unmatched accuracy, transparency, and speed in every service we provide. Here’s why we stand out.
Regulatory Expertise
Decades of experience with Indian pharma laws, NDCT Rules, and drug authorities.
End-to-End Documentation
We handle the full cycle — preparation, submission, follow-up, and closure.
Trusted Government Liaison
Strong working relationships with DCA, CDSCO (Zonal & HQ), and DCGI.
High Approval Success Rate
Proven track record of getting licenses and registrations approved on time.
Specialized Team
Regulatory professionals with technical and legal know-how in pharma.
Faster Market Entry
Helping clients reduce turnaround time and launch products compliantly.
Our Capabilities
We offer regulatory expertise that spans across product registration, compliance filings, government liaison, and pharma documentation for Indian and global markets.
- Preparation and filing of CT forms under NDCT Rules 2019
- Dossier preparation for R&D, DCGI, and CDSCO submissions
- Licensing support for manufacturing, sales, and repacking units
- Import/export licensing and international product registration
- eCTD preparation for NDA, ANDA, IND, and DMF submissions
- Labeling and artwork approval under Rule 96
- Regulatory response handling and audit support
- DSIR, FSSAI, WHO-GMP, and Free Sale Certificate assistance
- Market entry planning and regulatory gap analysis
- Trademark, NSQ handling, and court-compliant submissions
What Our Clients Say
We’ve supported pharmaceutical companies, importers, and R&D sites across India in achieving faster approvals and smoother compliance. Here’s what some of our clients have
Frequently Asked Questions
Have questions about our services, licensing procedures, or regulatory timelines? We’ve answered some of the most common queries here.
What types of licenses do you help obtain?
We assist with a wide range of pharmaceutical licenses including manufacturing (Form 24, 25, 27, 28), loan and repacking licenses, retail and wholesale sales licenses, Schedule X licenses, NDPS licenses, and more.
Can AAHVI help with import and product registration?
Yes. We handle the full process of product registration and import licensing for APIs and formulations. This includes dossier preparation, regulatory submissions to CDSCO/DCGI, and securing CoPP and WHO-GMP certificates.
Do you assist with eCTD submissions and dossier compilation?
Absolutely. We prepare, review, and submit eCTD dossiers for NDAs, ANDAs, INDs, and DMFs according to regional and international regulatory requirements.
What regions do you serve?
We serve pharmaceutical companies across India and provide documentation support for international submissions as well. We regularly work with clients in Telangana, Andhra Pradesh, and other major pharma hubs.
How long does it take to get a license or approval?
Timelines vary depending on the type of license, completeness of documentation, and government processing time. However, our team ensures accurate, complete submissions to avoid delays and speed up approvals.
Do you also offer distribution of pharmaceutical products?
Yes. We distribute a wide range of approved formulations to hospitals, clinics, medical stores, and institutions within the region.
How can I get started with AAHVI?
You can fill out our contact form, call us directly, or request a consultation through our website. Our team will respond promptly to understand your requirements and guide you forward.
Insights & Updates from the Pharma Regulatory World
Stay informed with expert articles, compliance tips, and regulatory updates from AAHVI’s experienced team. We simplify complex regulations so you can focus on what matters — growing your business.
