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  Pharmaceutical Project Management  

Pharmaceutical Project management:
The services that we offer through pharmaceutical Project management are as followed:


Engineering services

Equipment and processing specification

Technical advisory services

Management services

Regulatory services

We readily offer services to set up the plant or section as per WHO GMP/MHRA/USFDA/ANVISA/NAFDAC etc… and many of the regulatory authorities.

We also offer Contractual Analytical Services:
Development of specification and method of analysis

Structural identification and quantization of impurities and polymorphism using techniques such as LC/MS/MS and X-Ray Diffraction

Separation and purification of impurities

Method development, optimization and validation

Structural identification of medical specimen such as kidney stones, gall bladder stone

Pharmaceuticals Industry

Food Industry

Validation and Support Activities

Validation Master Plan (VMP)

Qualification Protocols like IQ, OQ, IOQ, PQ

Validation Protocol for Utility, Systems, Processes, Cleaning, Analytical Method

Validation Summary Reports


Actual qualification and validation support for Equipments, Systems, Processes

Techniques For Sample Analysis

Physicochemical attributes

Latest Technique Viz. UV, IR, HPLC, GC, LC/MS/MS, XRD

Purification and preparation of working standard

Certification of analytical reference standards via full chemical analysis

Microbiology Studies

Microbial Count

Sterility Testing

Endotoxin Testing

Identification of microbes up to genus and species level

Isolation, cultivation and storage of pure cultures

Verification counting of Biological indicators

Microbiological assays


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.