Pharma Consultancy

Pharma Consultancy

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Delivering Confidence Through Science and Compliance

Ultra Bio Instruments is your trusted partner for impurity assessment, risk evaluation and regulatory compliance solutions tailored to global standards that help pharmaceutical organizations ensure product quality and safety. Our expert team combines scientific depth, advanced computational tools and extensive regulatory experience to deliver credible, audit-ready solutions.

Scientific and Regulatory Consultancy

Mutagenicity Assessment of Impurities (ICH M7)

• Hazard classification using validated (Q)SAR software
     • Statistical-Based Models
     • Expert Rule-Based Models
• Scientific justification reports and regulatory documentation for global submissions.

Nitrosamine Risk Assessment & Safety Evaluation

• End-to-end risk evaluation and mitigation strategies.
• Advanced computational (quantum mechanics) approach for higher     Acceptable Intake (limit) of nitrosamines.

Extractables & Leachable Qualification (ICH Q3E)

• Study design and qualification of packaging materials.
• Risk-based evaluation aligned with regulatory expectations.

Elemental Impurities Assessment (ICH Q3D)

• Acceptable daily intake assessment and limit setting.
• Data interpretation and submission-ready documentation.

Qualification of Non-Mutagenic Impurity

• Biological safety evaluation of the impurity or degradation product above qualification level.
• Integrated toxicological assessment as recommended by the EMA Reflection Paper

Control Strategy for Genotoxic and Nitrosamine Impurities

• Scientifically designed Control Strategy based on purge assessment for Genotoxic & Nitrosamine impurities .
• In line with the requirement of ICH M7

Validated Tools & Recognized Methodologies

  • We use internationally recognized (Q)SAR and computational tools validated under ICH M7.
  • All platforms are recognized by FDA and EMA, ensuring high credibility and acceptance of scientific evaluations.

Trusted by Industry Leaders

  • Regulatory-compliant & validated methodologies
  • Experienced team with proven domain expertise
  • Quick turnaround & quality-assured deliverables
  • Competitive pricing and scalable service models
  • Strong relationships with leading pharma clients

Partnership

  • Collaborate with a team that blends scientific excellence with regulatory precision.
  • Our consulting services ensure compliance, minimize risk, and accelerate your product development journey
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