Welcome to Biotrains

Biotrain’s consultants and experts provide assistance to clients in the
Pharmaceutical, biotechnology, Medical device and Health care.
With diverse and in-depth experience of our team of Expert scientist
and Regulatory specialist we provide advice and services in many
other fields.

Click to know more

Lyophilization/ Freeze Drying

  • Product Characterization
  • Formulation Development
  • Process Development and Optimization
  • Diagnostics & Personalized Medicine
  • Scale Up and Tech Transfer
  • Cycle development and Optimization

Have a look at one of our conference on LYOPHILIZATION/ FREEZE DRYING

Quality by Design (QbD ) & PAT

  • Formulate Strategy QTPP/CQA/CPP Design Space ..DoE Control Strategy Risk Management Training / Handholding Implementation ../ PAT Resources / Leaders Statistician Technology Transfer Follow up Desired documentation Review ANDA
  • Gap Analysis
  • QbD Assesment

Know more about the QUALITY BY DESIGN (QBD ) & PAT training

Pharmaceutical Regulatory affairs consulting

  • Analytical Research and development ( cGMP)
  • Quality Assurance
  • On-Site Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP) Training
  • On-site GMP Audits
  • Interpretation and Compliance with ICH Quality Guidelines
  • Writing CMC sections for Regulatory Documentation
  • Preparing for Regulatory Review & Inspection
  • Transferring processes from R&D to Manufacturing
  • Portfolio Integration during M&A activities

Drug Developments 

  • CMC Strategy Development
  • Release testing strategies for drug products and API
  • Analytical method development, validation and inter laboratory method transfer
  • Integration of API & Drug Product strategies through development of Materials Science approaches.
    Supporting and optimising the R&D to manufacturing interface
  • Salt & Polymorph Selection
  • Particle Sizing & Morphology
  • Analytical Methods Design, Development, Validation & Transfer
  • Specification Setting
  • Support for Drug Delivery Options and Planning a Biopharmaceutics Strategy