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Pre-formulation Studies

A team engaged to perform Pre-formulation studies having core expertise with end-to-end profiling of molecules on

  • Polymorph Screening & Selection
  • Salt Form Selection
  • pH Solubility & Stability
  • Solid-state & Solution-state Stability
  • Photo-stability
  • pKa & Partition Coefficient Determination
  • Hygroscopicity
  • Morphology Assessment
  • Solubility Studies
  • Excipient Compatibility
  • Leachables & Extractables Studies
  • Flowability
  • Particle Size Determination
  • Container – Active Pharmaceutical Ingredient (API) Interactions

Technical Capabilities:

  • Thermal analysis: DSC (Differential Scanning Calorimetry), TGA (Thermogravimetric Analyzer)
  • Dynamic Vapor Sorption/Desorption
  • pXRD (X-Ray Diffraction)
  • FT-IR (A Fourier Transform Infrared) Spectrometer Capillary Electrophoresis
  • SEM (Scanning Electron Microscopy) & TEM (Transmission Electron Microscope)
  • Potentiometer
  • Hot-stage Microscopy
  • Laser Light Diffraction Particle Size Analyzer
  • Intrinsic Dissolution
  • Head Space GC Analyzer

Formulation Development

Company’s performance edge is based on offering Quality-By-Design (QbD) concepts at all stages of formulation development. The Design of Experiments (DOE) along with relevant time scale and risk assessment helps us to develop the strategy for further experimentation.

Dosage forms handled:

  • Tablet: Immediate-release, Sustained-release, Delayed-release, Film-coated, Orally disintegrating
  • Capsule: Powder, Granule Filling
  • Pelletization: Into Tablet or Capsule Filling
  • Powder: Powder in Bottle
  • Liquid: Solution, Suspension, Emulsion
  • Semi Solid: Cream, Ointment, Gel, Lotion
  • Parenteral: Injections (Solution, Lyophilization, Emulsion based, Nano Technology based)

Intellectual Property Management

Our expertise in the IP Management has deep purpose of the business. V-Ensure not only offer the strong IP coverage to its Clients but also participate in collective IP strategy for high value creation of the project and molecules.

The in-house Intellectual Property Group is equipped with relevant Patent Software and wide experience of Litigations and Circumnavigation of IP case studies with respect to Global Patent Regulations. The high integrity of IP Coverage to our Clients is uncompromising business aspect at V-Ensure.

Analytical Development & Validation

At V-Ensure, the balancing act of formulation research and analytics is strongly backed up by our high focus and concentrated approach of relevant talents, the wide ranges of HPLCs and allied equipments. Our Analytical Research and Development offers standalone services and supports our formulation development activities at each stage in development. The analytical team has the expertise in the method development and validation for highly complex molecules and dosage forms, this expertise allows us to ensure time bound development. Our extensive analytical development and validation services include:

  • API Characterization
  • Method development, validation and transfer
  • Specifications development
  • Stability studies
  • Photo stability studies
  • Analytical methods for cleaning verification and validation
  • Forced degradation studies and stability indicating method development
  • Dissolution and drug release profiling

Stability Studies:

We offer GLP compliant ICH stability testing services. All our walk-in stability chambers are continuously monitored. The electricity back-up assures sample integrity. The following climatic zones are available:

  • 5°C
  • 25°C/60% RH
  • 30°C/65% RH
  • 30°C/75% RH
  • 40°C/75% RH
  • Photo stability chamber

BE Study Management

Our understanding of the molecule and technical input facilitates the Clinical Centers (CRO) to establish robust study protocols. V-Ensure's connectivity within the CRO community is wide spread and efficient. Our Turn-key development projects provided high exposure in the areas of clinical management. V-Ensure's strategic partnerships with key CROs offer clients an integrated and cost effective solution. Each study is thoroughly designed and coordinated with Clinical Centers ensuring high success rates in BA/BE.

Technology Transfer

V-Ensure has tied up with strategic contract manufacturing centers which are USFDA / EU GMP approved. Bio batches/ Clinical supplies are executed and prepared in presence of the scientists who have worked on the project and are present till the execution and analysis is complete and confirmed.

Operational Bandwidth is the USP of V-Ensure. Our clients have the competitive edge through singular Project Management approach resulting into seamless Technology Transfers. A visionary approach provides high clarity and skills during the entire value chain of dossier development and submissions in the USA, Canada, Europe, Australia and other advanced markets of the world.

Scale-up and Validation activities are performed at the CMO in presence of the Core Team engaged into the Formulation and Analytical Development. Our clients have superior control over outsourced projects amid constant involvement by V-Ensure’s team for Technology Transfers.

Regulatory Services & e-CTD Filing

The right knowledge and inbuilt scientific culture is present within the individuals at V-Ensure. Company’s core and existential feature is the dossier development derived from experience and deploying relevant newer technologies in tandem with market demands. Dossier Development is strongly facilitated by Regulatory Affairs and the urge of Quality Assurance at each milestone covered. A consolidated approach of formulation and analytical development has following features:

  • Periodic Briefing of Document Preparation
  • Controlled Communication
  • Review of Protocols, Reports
  • Stringent Framework of SOPs
  • Review of Critical Documents i.e. MBR/BMR
  • Preparation of CTD and e-CTD along with Corresponding Amendments
  • Preparation, Review and Submission of ANDA and sANDA