Pharma Products - Research and Development

At VerGo Pharma Research, our R&D Division provides comprehensive end-to-end pharmaceutical product development services, specializing in generic formulations. As a trusted Pharma Product Development CRO, we support global clients in developing robust, regulatory-compliant products for submission to major health authorities.

As a specialized provider of Pharma Powder for Suspension (PFOS) development and manufacturing services, VerGo Pharma Research has the technical and regulatory capability to support challenging suspension formulations. Additionally, pharma liquid products development services cover both aqueous and non-aqueous solutions, suspensions, emulsions, and reconstitutable liquids. We develop and manufacture oral and ophthalmic liquids.

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.

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.