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Research and Development

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R&D Division of VerGo Pharma Research Laboratories is catering end to end development of NCEs and Generic formulations for submission to various regulated agencies across globe.

Product development

We have expertise in various technologies for development of conventional to complex delivery systems. Our success is attributed to application of Quality by Design concept throughout development process for delivery of robust products. We have capability to develop high potent molecules in our special product area which is designed to handle the potent molecules. We have successfully developed more than 50 products which includes NCE -1 products, complex generics and innovative combination products for clinical studies. Our product development team includes 50+ qualified scientists with diverse experience in different technologies and scientific expertise.

Our Expertise
  • Tablets : IR, SR, ER, DR,ODTs, MUPS, Sublingual & Effervescent dosage forms
  • Capsules : Powder, Granules and Pellets filled in capsules
  • Powder amd Granules : Sachets and Bottles
  • Oral Liquids : Solutions, Suspensions and Emulsions
  • Parenterals : Ophthalmic and solutions for injection
Development Specialites
  • First Generics
  • Complex Generics
  • Niche Generics
  • Generics
  • Non-infringing & PIV formulation
Quality
  • QbD based development
  • Statistical design of experiments
  • ElectronicLab Notebook
  • Development QA
State of the art infrastructure
  • General Development Lab
  • Dedicated Special product development
  • Low humidity area
Customer focus
  • End to end services from development to filing
  • Integrated PM team
  • MSP
  • Timely deliveries

Product development

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Analytical Development

State of the art Analytical R&D facility to meet the ever-rising demands of the global healthcare industry. Experience scientists and advanced capabilities lead to fast and scientifically sound results. We support the development of drug substances, impurities, by-products & drug products and are focused on accelerating the product development cycle.

Analytical Development Services:
  • Method Development by HPLC, UPLC and GC Techniques
  • Method Validation as per ICH, USP and ANVISA guidelines
  • Cleaning Methods and their validation
  • Inter-laboratory Method Transfers
  • API Characterization
  • Reverse Engineering
  • Impurity Profiling and Characterization
  • Dissolution Profiling
  • Qualification of secondary standard
  • Stability Assessment & Photo Stability
  • Structure Elucidation & Impurity Identification
  • Analytical support for Dossier filing
Equipment Capabilities:
  • 20 HPLC/UHPLC (Waters, Agilent, Shimadzu &Thermofischer) with VWD / DAD and RID Detector connected to Chromeleon Software Ver 7.20 with e-sign implementation.
  • RRLC with DAD detector.
  • Dissolution Type I, II, III – Agilent and Electrolab with syringe pump for Auto sampling.
  • UV Visible spectrophotometer connected to UV probe software (Shimadzu)
  • DSC TA (MDSC) -90° to 550°
  • Preparative HPLC with the capacity of 100ml/min available for impurity isolation
  • Karl Fischer titrator connected to Tiamo software
  • ELN for documentation
Achievements:
  • Related substances and Dissolution method developed for low dose products with quantification level of below reporting threshold.
  • Related substances method developed for Multi-Vitamins with four components.
  • Developed analytical method superior to BP monograph.

Electronic Lab Note Book

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Development Quality Assurance

VerGo’s R&D is integrated with inhouse Development Quality Assurance team which ensures compliance to all quality procedure during routine Research & Development activities.

Major Responsibilities:
  • Lay down the written procedures to comply with quality standards for development activities.
  • Provide proper guidance as per regulatory requirement and to impart training on quality systems to development team.
  • Ensure each stage of product development for compliance as per defined quality systems.
  • Assure implementation of quality by design concept during development to ensure robustness of product and process.
  • Review and maintain the generated development documents.
  • Ensure maintenance of equipment, systems and facilities to assure quality standards for development activities.
  • Continuously focus on Improving quality, safety and environment aspects.
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