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PharmExpert Consultant LLP
De-risk your pipeline with expert development, transfer and impurity control.

Product Development Technology Evaluation

Development and manufacturing decisions hinge on sound science and control. PharmExpert brings deep technical expertise to product development under QbD, technology transfer, process optimization, troubleshooting and the impurity-control strategies that underpin a robust, registrable product.

From developability and CMO development through scale-up, troubleshooting and impurity profiling and justification, we help you build quality into the product and keep processes in a demonstrable state of control.

01

Product Development (QbD & CMO)

Quality-by-Design product and process development, including development with and oversight of contract manufacturing organizations.

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02

Technology Transfer Support

Structured scale-up and site-to-site / CMO technology transfer that preserves process understanding and control.

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03

Process Optimization

Data- and science-based optimization of manufacturing processes for yield, robustness, quality and cost.

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04

Troubleshooting

Rapid, root-cause-driven troubleshooting of manufacturing, formulation and analytical problems.

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05

Controlled Strategies of Impurities

Control strategies for impurities — including genotoxic and elemental impurities — across the product lifecycle.

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06

Impurity Profile & Justification

Impurity profiling, qualification and regulatory justification of specifications for drug substance and product.

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Standards & Frameworks
  • ICH Q8(R2) (QbD)
  • ICH Q11 (development of drug substances)
  • ICH Q6A
  • ICH Q1 (stability)
  • WHO TRS 961 Annex 7
  • ICH Q8–Q12
  • EU GMP Annex 15
  • 21 CFR 211
  • FDA Process Validation (lifecycle)
  • Six Sigma / statistical methods
  • ICH Q9 (QRM)
  • FDA OOS guidance

Talk to a product development technology evaluation specialist

Tell us about your challenge and we'll propose a scoped, independent engagement — with a transparent quote.

Request an Audit +91 70468 82130