Different interpretations = different review risk
Reduce Interpretation Gaps Before They Become Regulatory Questions
Help your CMC team reach justified decisions faster, with greater consistency and stronger scientific rationale
same data. different regulatory conclusions
The same dissolution profile can produce different regulatory conclusions.
Not because the calculation changed.
Because the assessment changed:
- Timepoint selection
- Eligibility criteria
- Regulatory pathway
The challenge is rarely calculating f2.
The challenge is knowing whether the assessment itself is correct.
RegXpertPRO helps pharmaceutical professionals apply scientific and regulatory expectations consistently before conclusions reach reports, submissions, and regulatory review.
Most calculators generate numbers
Most pharmaceutical decisions require more than that.
A calculator can tell you: f2 = 54
But it cannot tell you:
- Were the correct timepoints used?
- Was f2 even applicable?
- would FDA and EMA/ ICH M9 reach the same similarity conclusion?
- Is the assessment ready to support a submission?
- Can the rationale be justified during regulatory review?
The risk is rarely the formula.
The f2 formula does not change.
But eligibility, timepoints selection, and pathway expectations can change the conclusion.
SCIENTIFIC DECISION CALCULATORS & TOOLS
RegXpertPRO calculators and tools are designed around recurring scientific and regulatory decisions where guidance must be interpreted before it can be applied.
Unlike traditional calculators that simply generate numbers, RegXpertPRO tools are designed to help users understand the scientific and regulatory context behind the result.
f2 Select Web
For dissolution profile comparisons of IR drug products where timepoints selection affects the outcome.
Browser-based f2 calculator and guidance-aligned auto-timepoints selector for immediate - release dissolution profile comparison.
When experienced scientists reviewing the same dataset reach different answers, the challenge is no longer in the calculation itself. It's in the consistent interpretation and application.
f2 Select Web helps users:
- Apply FDA's prerequisites for f2 calculation correctly and consistently
- Apply EMA/ ICH M9 prerequisites for f2 calculation correctly and consistently
- Identify eligible timepoints
- Flag ineligible timepoints
- Evaluate profile eligibility
- Generate assessment reports
Because different assessments can produce different conclusions from the same dataset.
Best for:
Desktop review, documentation, regulatory assessments, and report preparation
Pocket f2 Select
Mobile-friendly f2 decision support for review discussions and point-of-need use for immediate - release dissolution profile comparison.
Designed for moments when the teams need quick FDA, EMA/ ICH M9-guidance aligned time-point selection and f2 interpretation without reopening spreadsheets or rechecking guidance during discussion.
Best for:
Meeting-time discussions, quick assessments, and point-of-need decisions
Max RSD Calculator
A quick calculator for pharmacopoeial system precision checks.
Designed to support consistent interpretation of maximum permitted % RSD for system suitability for Assay test, based on the method setup and pharmacopoeial expectations.
Best for:
assay system precision, System suitability test (SST) limit discussions and quick reviewer checks.
Impurity Threshold QuickCheck
ICH Q3A/ Q3B Threshold Assessment
Determine applicable reporting, identification, and qualification thresholds using maximum daily dose (MDD) and ICH principles.
This QuickCheck converts TDI-based thresholds into the equivalent % at the entered MDD, where applicable.
Best for:
Early impurity assessment, stability discussions, specification review, and quick regulatory CMC checks.
need more than a tool?
Expert Advisory
Some challenges require interpretation, scientific justification, and regulatory strategy.
For teams that already have data, but need stronger analytical narrative, justification, and alignment before submission or deficiency response.
Support areas include:
- Analytical and Dissolution development reports
- Scientific justifications and Specification setting
- Impurity control strategy and limits
- Pharmacopoeial evaluation reports
- Analytical content in deficiency responses, investigations, and CAPA reports
Training & Masterclasses
Advanced training programs designed for pharmaceutical professionals who want to move beyond compliance and understand the rationale behind regulatory expectations.
Topics include
- Dissolution Method Development
- Bio-relevance and Dissolution assessment
- Analytical Drug Product Specifications
- Regulatory CMC Strategy
- Pharmaceutical Problem Solving
Training programs combine scientific principles, regulatory expectations, case studies and practical implementation approaches
built by a cmc practitioner
Practical Pharmaceutical Expertise
Founded by Pearl Pereira Nambiar, a pharmaceutical CMC and dissolution specialist with 23+ years of experience across analytical method development and specifications, dissolution evaluation, scientific justification, and regulatory deficiency responses.
RegXpertPRO was created from a simple observation:
Many regulatory questions arise not because data is missing, but because the same guidance is interpreted differently by different teams.
The mission is to make scientific and regulatory decision-making more consistent and transparent. Thus helping pharma teams reduce interpretation gaps before they turn into review questions, delays, or avoidable deficiencies.
Join Regxpertpro early access
For Pharma professionals who want early visibility into structured tools, regulatory deep dives, and pilot cohorts
Members receive:
- Early access to tools and pilots
- Structured execution frameworks
- Deeper regulatory interpretation insights
- Priority visibility into upcoming releases
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