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