Barhite Consulting Services

Barhite Consulting offers lower costs while providing higher engagement, striving for shorter timelines, and reducing risk.

Quality Control

  • Batch record review

  • Drafting and data verification for regulatory filings 

  • Technical report review 

  • Raw data review for drug substance, drug product, and intermediates, including in-process, release, and stability data

  • OOS and OOT investigations 

Infrastructure

  • Data management and archival

  • Launch and inspection readiness

  • SOP authoring, review, and optimization

  • Support with Quality systems

  • Lifecycle management 

Technical Project Management 

  • CMO/CRO Management 

  • Stability program management for drug substance, drug product, and intermediates 

  • Specification development per ICH Q3A, Q3B, and Q3C

  • Organizational tools

Barhite Consulting aims to alleviate the two major constraints confronting the biotech and pharmaceutical industry: time and money.

With an emphasis on efficiency, our services allow you to maintain a flexible team,
agile enough to shift priorities quickly,
robust enough to produce meaningful, positive impact. 

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