Our Services
Pharmaceutical Regulatory Affairs
Medical Device Regulatory Affairs
Food Supplements
Herbals & Ayurvedic
Contract Manufacturing
Pharmaceutical Project Management
Import/ Export
Artwork Design
Project & Training
  Pharmaceutical Regulatory Affairs  

We provide a full range of 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:

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.

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 :

       Asean Common Technical Dossier (ACTD)          Guidelines.
       South Africa (MCC-MRF-1) Guidelines.
       Brazil ANVISA Guidelines.

Dossiers compilation for submissions in :
        Central  America
        South  America
        North  America

Dossier compilation in Common Technical  Dossier (CTD) format for 

       Commonwealth of Independent States
       (CIS) Guidelines.
       South East / West Europe Guidelines.



  • New Chemical Entities
  • Generics   (Abbreviated New Drug Approval)
  • OTC (Ayurvedic/ Herbal & Chemical)    
  • Investigational New Drug (IND) Application  
  • New Dug (NDA) Application  
  • Investigation New Drug Approval
  • Medical Devices      
  • Nutraceuticals      
  • Biotechnology Products      
  • Biological, Blood Products
  • Vaccines
  •  Food /Food Supplements                

Regulated markets
   European Union

Semi- regulated markets

 Asia Pacific, Asean Countries, all CIS Countries, Middle- East, African Countries, Latin America.

Our Advantage
Success and Us
Everything and Anything

Spark Pharma Regulatory is managed by a industry trained regulatory professional having invaluable Pharma experience from Reputed pharmaceutical company.

We assist our clients by guiding the product development in line with the country specific requirements, data generation, document compilation for submission to various Regulatory Agencies all over the world.

The registration being the pre-requisite for export to any market, the client gets all round assistance in technical data generation and regulatory strategy to enter new markets. Thus, enhancing their market portfolio and revenues.