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Innovation, Development and Analytical Services

 

Our team of scientists and researchers (phds, masters, pharmacists) create sustainable, safe and high quality product delivery systems for cutting edge formulations.

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  • Design, Prototype & Validate products

  • Products based on customer specifications or benchmarks

  • Innovative products from concept to proof

  • In-house formulation library

  • Improve upon existing product characteristics

  • Redesign or Reformulate for sustainable, greener or natural products

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Technical Services offered:

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  • Contract Development & Manufacturing

  • Innovation & Development

  • Method Development, Validation & Verification

  • USP/ EP Compendial Testing

  • Impurity Testing

  • Transfer of Technology

  • Method Development and Validation

  • 510(k) submission assistance

  • ANDA transfer of site and manufacturing

  • Product design and development

  • Formulation development/ redevelopment

  • Product data analysis

  • Clinical supplies scope

  • Propellant changes to meet regulatory requirement

  • Packaging stability, shelf life and validation studies

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Test method  development and transfer using:

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  • Lab Information Management System (Part 11 Validated) with Audit Trail

  • High Performance Liquid Chromatography (HPLC)

  • Gas Chromatography with Flame Ionization (GC)

  • Fourier-Transform Infrared Spectrometer (FTIR)

  • Stability Chambers (Room temperature/ Accelerated)

  • Freeze Thaw Test Cycles

  • Emulsion Stability

  • Karl Fisher Titrator and Coulometer

  • Viscosity (low and high viscosities)

  • pH Meter(s), Refractive Index Meter

  • Onsite Rapid Microbial (USP 61/62)

  • Antimicrobial Effectiveness Testing (USP 51) - External

 

Regulatory Assistance and Consulting:

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  • Consumer Products Regulations for Marketers- VOC, CPSC, DOT, GHS, WHIMS, ReACH

  • Chemical Products Manufacturing Regulations - FDA, EPA. CHPA, TTB DOT, DfE, OSHA

We provide analytical services including:​
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  • Clinical Supplies Scope

  • Custom product formulations

  • Regulatory compliance

  • Technology Transfer

  • Formula modifications and redevelopment

  • Shelf life & Stability studies

  • Product, Process & Packaging Validation

  • Product innovations, technologies and collaboration

  • Product troubleshoot and reformulation

  • Product appearance and performance attributes​

  • Product samples and lifecycle stability testing

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