what we provide

Services for Regulatory and Statutory Compliances (Approvals/Licenses/ Permissions)
  • Product registrations & compliance management for R&D Centres as per NDCT Rules 2019.
  • Licensing & approvals from state drug authorities (DCA) Telangana, Zonal office CDSCO – Hyderabad and DCGI – New Delhi as per Drugs and Cosmetics act 1940 and rules 1945.
  • Assistance in factory, labour, and legal compliance.
  • R&D Recognition from DSIR (Department of Scientific and Industrial Research) Registration and Renewal.

R&D Sites: Preparation and Approvals of EIGHT SCHEDULE of NDCT Rules 2019.

    • Preparation of Protocols and Reports of Technology Transfer of products from R&D site to various manufacturing facilities).
    • Form 29/30 (license for manufacturing drugs for examination, testing, and analysis)
    • Form CT-01/02 (Grant of Registration of Ethics Committee Relating to Clinical Trial or BA And BE Study.
    • Form CT-04/06 (Permission to Conduct Clinical Trial of New Drug or Investigational New Drug)
    • Form CT-07 (Permission to Conduct Bioavailability or Bioequivalence Study of New Drug or Investigational New Drug
    • Form CT-10/11 (Test License NOC for approved API and Unapproved Formulations)
    • Form CT-12/14 (Test License NOC for Unapproved API and Unapproved Formulations)
    • Form -12 (Import of approved API/Formulations for test and analysis)
    • Form CT-15 (License to manufacturing of unapproved API)
    • Form CT-16/17 (Import of Unapproved API/Formulations for test and analysis)
    • Form CT-18/19/20 (Grant of Permission to Import (API and Formulation) New Drug for Sale or for Distribution)
    • Form CT-21/22/23 (Permission to Manufacture New API and Formulation for Sale or for Distribution)
Licensing & Approvals from state drug authorities (DCA):

Manufacturing: –

    • Registration of ODLS/ONDLS/SUGAM/NSWS/IPDMS
    • Formulation/Bulk Drugs in Form 24/25 (API and Orals) (Grant, License Retention and Amendment).
    • Formulation/Bulk Drugs in Form 27/28 (API and Schedule C,C1 (Injections) (Grant, License Retention and Amendment.
    • Repacking License in Form 25B (Grant, License Retention and Amendment)
    • Loan Licenses in Form 24A/25A and Form 27A/28A (Grant, License Retention and Amendment).
    • Formulation in Form 27D-Large Volume Parenteral (Grant, License Retention and Amendment).
  • Approval/Deletion of additional products (API and Formulations)
  • Change of Premises of Manufacturing facility.
  • Change of Firm name.
  • Change of Constitution.
  • Change of Directors
  • Change of Technical Staff
  • Change of Composition.
  • Change of Specification.
  • Specific Export Quantity (NOC) of API and Formulation for manufacturing.
  • Dual Use NOC for drug (bulk and finished form) and cosmetics,
  • Grant/Renewal/Additional products of Cosmetics preparations.
  • GMP Certification for Manufacturing facility
  • GLP Certification for Quality Control Laboratory
  • WHO GMP Certification of Products (API and Formulations)
  • CoPP (Certificate of Pharmaceutical Products)
  • Free sale Certificate of Export Products
  • Non-Convection Certificate
  • MMC (Mfg.&Mrktg.) Certificates.
  • Performance Certificate.
  • Production Capacity Certificate
  • NEUTRAL CODE Certificate
Sales (Grant, Renewal & Amendment)
  • Documents Preparation for retail sale license in Form 20 and Form 21
  • Documents Preparation for wholesale license in Form 20B and Form 21B
  • Documents Preparation for Schedule X wholesale and retail license in Form 20G
  • Documents Preparation for NDPS 1 License.
  • Change of Premises, Constitution, Firm name, Directors, Pharmacist and Competent person in all sales licenses.
  • Submissions at Regulatory Govt. Offices in State FDA, CDSCO- Central, Zonal and Sub Zonal Offices
  • Submission of Govt. fee for various Licenses, NOCs and Permissions.
  • Submission, Meetings and Collection of Test Reports from Govt. Labs (NABL, CDTL/CDL etc.,)
  • Participation in SEC meetings at DCGI-New Delhi for NDA/ANDA in India.
  • Technical and Regulatory Support for queries by Drugs authorities & officers.
eCTD Preparation & Submission Services

We specialize in compiling and submitting electronic Common Technical Documents (eCTD) required for pharmaceutical regulatory approvals globally. The eCTD format is mandated by authorities such as the US FDA, EMA, Health Canada, TGA (Australia), and Japan’s MHLW.

Our support includes:

  • Preparing INDs, NDAs, ANDAs, and DMFs in eCTD structure

  • Managing Modules 1 to 5 with proper validation

  • Ensuring region-specific formatting and hyperlinking

  • Liaison with global agencies for submission tracking

  • Technical QC and compliance verification
    This service is crucial for clients targeting international markets or needing to submit to central regulatory agencies using accepted global formats.

Import & Product Registration

Bringing a pharmaceutical product to market — especially from overseas — involves critical steps that demand precision. We help you meet CDSCO and DCGI regulatory standards through seamless product registration and import licensing services.

We manage:

  • Product dossier preparation for Indian and non-EU submissions

  • Import license applications for APIs and formulations

  • CT forms (CT-18 to CT-23) for importing new drugs for distribution or testing

  • Support for CoPP, Free Sale Certificates, WHO-GMP approvals, and Neutral Code certificates

From the first submission to final approval, AAHVI acts as your regulatory partner to ensure 100% compliant product entry into the Indian market.

Distribution Services

In addition to our consultancy, AAHVI offers robust pharmaceutical distribution — delivering licensed, high-quality medicines to hospitals, clinics, medical stores, and healthcare institutions.

Our distribution network covers:

  • General & specialty formulations: tablets, capsules, syrups, suspensions, drops, injections

  • Critical care products including LVPs like RL, NS, DNS, and Metronidazole

  • Eye drops, ENT medications, paediatrics, and dermatologicals

  • Topical preparations (ointments, lotions, creams) and nutraceuticals

Every product is handled with strict regulatory adherence, ensuring quality and timely delivery — supporting better healthcare outcomes.

Specialized Regulatory Liaison & Representation

AAHVI PHARMA acts as a professional intermediary between your company and various national regulatory bodies. Our strong ties with State DCAs, CDSCO Zonal offices, and DCGI (HQ – Delhi) ensure streamlined communication and quicker approvals.

We help with:

  • Representing clients at SEC (Subject Expert Committee) meetings for NDA/ANDA

  • Test report coordination with CDTL/CDL labs for NSQ samples

  • Participation in discussions for MRP violations or product inquiries

  • Handling Form 17 sample testing procedures

  • Legal liaison for court submissions or audits.
    This service minimizes risks, saves time, and builds confidence with regulatory authorities.

Artwork & Labeling Compliance

We assist in the review, correction, and approval of packaging and labeling materials as per regulatory standards.

What we do:

  • Ensure compliance with Rule 96 under the D&C Act

  • Review layout, therapeutic claims, warnings, batch details, etc.

  • Coordinate approvals with CDSCO for market authorization

  • Stay updated on DCGI notifications for changes in label rules

  • Prevent packaging-related rejections and NSQ classification

This is essential for launching new products, exports, and compliance during audits.

Dossier Compilation & Submission

We offer end-to-end dossier preparation services for various pharma regulatory needs — both for India and international agencies.

Our capabilities include:

  • Preparing technical documents for R&D site approval

  • Compiling documents for Form 24, 25, 27, 28 submissions

  • Assembling CoPP, WHO-GMP, and CT forms

  • Regulatory gap analysis and quality checks

  • Supporting CTD, ACTD, or local formats as per country guidelines

Whether you’re preparing for first-time submission or renewals, our team ensures that every document meets official expectations.

Audit Preparation & GAP Analysis

We conduct internal audits and risk evaluations to help your facility remain compliant with all pharma manufacturing and sales regulations.

Services include:

  • GMP readiness audits (mock inspections)

  • Evaluation against NDCT Rules and D&C Act requirements

  • Action plan for addressing deficiencies

  • Documentation checklists and facility walkthroughs

  • Assistance during regulatory inspections

A proactive audit approach helps avoid license cancellation, penalties, and delays.

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