The Founder President & CEO, Mr. Sudhanshu Kumar Techno commercial expert of the Indian API Pharmaceutical Industry, has over three decades of unique experience in the pharmaceutical Industry from middle management to the position of Chief Executive Officer, in a unique combination of some of the biggest names in the Indian pharmaceutical Corporations. He continues to serve on the executive boards of several national and international Organizations.

Contact Info

Regulatory Affairs

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GLOBAL PHARMACEUTICAL REGULATORY AFFAIRS SERVICES

We provide a full range of API, Food and Pharmaceutical Regulatory Affairs consulting services to the Pharmaceutical, Biotechnology and Healthcare Industries. Our expertise covers all stages of the product lifecycle and each service is delivered by a specialist in their field with the relevant knowledge and experience.

Our Services Include

Dmf Services

Drug Master File - US DMF - European DMF

Drug Master File (DMF) is a master file containing complete information on an API/Bulk Drug Substance.It is a submission to FDA covering factual and complete information on its chemistry, stability,purity,impurity profile,packaging and cGMP status of any API.

The Main Objective of DMF is to meet regulatory requirements and for Market Authorization (MA).

Our Expertise
  • Compilation of complete DMF & Submission of the same.
  • Complete support for preparation of necessary documentation and submission to US FDA along with answers to Post submission queries.
  • Preparing US DMF for Active Substance (Bulk Drug), Excipients, Intermediates, Primary packaging material & submitting the same.
  • Reactivation of Inactive US DMF, Filling Annual Reports , Submitting LOA letters to clients and FDA.
Our Experience
  • We have Filled more than 40 DMFs in USA for Type II - Active Ingredient (API) type
  • III - Primary Packaging Material & Type IV - Excipients
  • Prepared & compiled more than 100 DMFs for Regulated & Semi Regulated Market..
  • Our services are tailored to meet client’s requirements, and add value to their company by minimizing both time and money spent
  • We also perform the following studies, in co-operations to DMF preparation:
    • Structural Elucidation Studies
    • Analytical Report (COA)
    • Analytical Method Validation
    • Process Validation
    • Stability data studies
    • Determination & Validation of Potential Impurities & Solvent Impurities

    (All the data supported by necessary Chromatograms & Spectrums)

  • Preparation and filing of Registration dossiers for submission to various regulatory agencies all over the world (including eCTD, CTD format & ACTD Format).
  • Drug Master File (DMF) compilation for open and closed part.
  • Preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources.
  • Expert reports on Quality , Pre-clinical and Clinical
  • Orphan Drug Application Preparation and Submission.
  • Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.
  • Assistance in Response to queries for submission to the Regulatory Agencies.
  • Total development of product from lab scale to pilot plant scale to actual production scale for Drug Substance and Drug product.
  • Prepare summary of product characteristic (SmPC), Pack Insert, Product rationale.
  • Periodic Safety Update Report (PSUR) preparation.
  • Provide analytical support in analytical method development / validation, Routine analyses of products by HPLC/GC/MS etc.
  • Complete stability programme management service is provided as per ICH guidelines / special requirements in a cGMP and GLP compliant environment.
    • D402200000003671548-LROR D505A27C23F524081A6DEA343A78B8D38-IN
  • Monitoring and liaisoning with the CRO’s for Clinical and BE Studies.
  • Preparation of Site Master file
  • Compilation of dossier as per latest country specific guidelines
Dossier Compilation As Per
  • US/EU (CTD)
  • Asean Common Technical Dossier (ACTD) Guidelines.
  • South Africa (MCC-MRF-1) Guidelines.
  • Brazil ANVISA Guidelines.
Dossiers Compilation For Submissions In
  • US/EU/UK
  • Asia
  • Africa
  • Central America
  • South America
  • North America
  • South Africa
Dossier Compilation In Common Technical Dossier (Ctd) Format For
  • US/EU/UK
  • Commonwealth of Independent States
  • (CIS) Guidelines.
  • South East / West Europe Guidelines.
Expert Reports
  • Quality
  • Pre-clinical
  • Clinical

Nonclinical Study Reports (Module 4)
Clinical Study Reports (Module 5)

Registration Assistance
  • Worldwide Regulatory Consultation of Human medicines.
  • Worldwide Regulatory Consultation of Veterinary medicines.
  • Worldwide Regulatory Consultation of Medical Devices.
  • Worldwide Regulatory Consultation of Food.
  • Worldwide Regulatory Consultation of Dietary Supplements.
  • Worldwide Regulatory Consultation of Herbal Drugs.