inconsistent interpretation = 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 f2 calculation changed.
Because the assessment around it changed:
- Timepoint selection
- Eligibility criteria
- Regulatory pathway
The challenge is rarely calculating f2.
It is ensuring that the correct prerequisites have been applied before the calculation is performed.
RegXpertPRO helps pharmaceutical teams apply recurring scientific and regulatory criteria consistently across products and projects, so conclusions are based on the same decision framework. This ensure the outcome doesn't depend on who selected the timepoints.
Most calculators generate numbers
Most pharmaceutical decisions require more than that: is this the right assessment?
RegXpertPRO scientific tools are designed around recurring decisions where guidance must first be interpreted before a calculation or conclusion can be applied.
They help make the criteria, reasoning and outcome explicit so the decision is easier to apply consistently across products, projects and teams.
SCIENTIFIC DECISION TOOLS
RegXpertPRO tools support recurring scientific and regulatory decisions where the challenge is not simply performing a calculation, but applying the right criteria to the right data.
Each tool is designed to make the decision logic visible alongside the result.
f2 Select
Auto timepoint selection for f2 calculation under FDA and EMA/ ICH M9 guidance prerequisites
Paste the complete dissolution profile from your Excel spreadsheet. Do not pre-select timepoints.
f2 Select independently applies the FDA and EMA/ ICH M9 prerequisites to:
- automatically determine whether conventional f2 is applicable
- automatically select the eligible timepoints for each regulatory pathway
- calculate f2 where applicable
- provide the pathway - specific conclusion and reasoning
So the f2 conclusion does not depend on which scientist selected the timepoints.
One complimentary full assessment available.
Impurity Limits QuickCheck
Set proposed impurity limits against the applicable ICH thresholds
Applies ICH Q3A/ Q3B thresholds based on maximum daily dose and impurity type, calculates the applicable maximum limit in % or TDI as appropriate, and assesses the proposed specification limit.
Where identification or qualification is triggered, Impurity QuickCheck also shows what data may need to be generated or what scientific rationale may be required to support the proposed limit.
Free to use
Max RSD Calculator
Apply pharmacopeial assay system-suitability precision limits consistently.
Determines the applicable maximum permitted % RSD for Assay System suitability (Drug substance and Drug Products) based on pharmacopeial requirements.
Free to use
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
This website uses cookies.
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.