Overview

Our R&D activities include research on new products and drug delivery platforms such as Extended/controlled release drug delivery, multiple-unit Particulate system (MUPS), multi-layer tablet technology, gastro-retentive drug, and hot-melt extrusion delivery for tablet and capsule dosage form.

Spheronic Lifescience having state of art facility for Research and Development to support development of different dosage forms for Emerging and Regulated Markets globally. Further, through our technology platforms which are developed in-house, we are also able to effectively formulate difficult products across a wide range of therapeutic categories. Our inhouse expertise of Intellectual property rights and Regulatory support team further strengthen our product development strategy.

Our R&D facility, is equipped with technologically advanced infrastructure. Furthermore, it is managed by well qualified and highly skilled team of scientists, backed up by state of the art testing facilities, ensuring timely development of differentiated products, that meet domestic and international regulatory standards. At Spheronic life Science Pvt. Ltd., we believe in supporting our Clients with shorter timelines, right from the Product Development phase, through stability profiles and commercialization stage.

Infrastructure

The facility is built in an area of about 2500 square feet with all modern equipments and infrastructure designed for development of Pharmaceutical Drug Products, and encompasses various functions such as Process Development, Formulation Development and Analytical Development.

Research and Development facility is built in an area of about 5000 square feet with all modern equipment’s and infrastructure designed for development of Pharmaceutical Drug Products, and encompasses various functions such as Formulation Development, Process Development, and Analytical Development.

R & D Team

We have excellent expertise in area of Formulation Development of different dosage form. Team possess excellent academic credentials with Bachelor, Master’s or Ph.D degree in different branches of Pharmaceutical sciences with Sound knowledge of Product development by Quality by Design (QbD) concepts and regulatory requirements. Team possesses Expertise in Product development, process development, process optimization, process Scale up, process validation Elevating Well-Being by Innovative Health Solution and technology transfer with good knowledge of pharmacokinetics and in vitro dissolution.

R & D Services

Formulation Development

Solid Oral Dosage form, Parenteral Dosage form, Powder/Effervescent dosage form

Analytical Method Development

Analytical Method development, Analytical Method Validation

Scale up/Technology Transfer

Scaling up and Technology transfer of Developed Product

Clinical/BE Study

Identification of CRO and conducting Bioequivalence study

Submission batches

Execution of Exhibit batch/Submission batches

Regulatory Documents

Regulatory submission Documents for dossier submission for respective regulatory agency

Formulation Development
  • Literature Search and patent landscaping
  • Pre- formulation Studies
  • Formulation Development and Optimization
  • Process Development and Optimization
  • Scale-Up and Technology Transfer
  • Process Validation Studies
  • Packaging Development Studies
  • Analytical method development & validation
  • Para IV / Non-infringing formulation development
  • NCE (-) and 505 b(2) formulation
Dosage form
  • Solid Oral Dosage form
    • Immediate-release Dosage form
    • Delayed Release Dosage form
    • Sustained/Extended Release dosage form
    • Effervescent/ODT dosage form
    • Amorphous Solid Dispersion
    • Pellets- IR/DR/SR
    • MUPS and Modified Release technology
  • Liquid Orals
  • Parenteral Dosage form