Statistical consulting, training and software for CPV, periodic product review (PQR/APR), process validation and analytical methods. We support pharmaceutical companies regulated by ANVISA, FDA, EMA and ICH.
Estatística Digital is a Brazilian consultancy specialized in statistics applied to the pharmaceutical industry and regulated (GxP) environments. We support quality, validation and development teams in carrying out, reviewing and automating the statistical analyses required by agencies such as ANVISA, FDA and EMA and by ICH guidelines. We combine technical consulting, training, an AI agent (Edu), Continued Process Verification (CPV) software and GuidanceStat, a regulated study planning platform that turns FDA and ANVISA guidance into guided workflows — all with a setup phase dedicated to each client's reality.
Tailored projects with inspection-ready statistical support. We work from study design to final documentation.
Technical training for teams that need to apply statistics under regulatory requirements.
Continuous statistical support, consulting agents and software to automate critical tasks.
We cover the main needs of pharmaceutical companies across three areas, in Portuguese, Spanish and English. Choose the solution that best fits your challenge.
On-site and on-demand courses in statistics applied to QA, Validation, Stability and R&D. Hands-on classes with real industry cases.
Learn MoreTailored projects in Quality Control, Quality Assurance (PQR/CPV), QbD, process validation, sampling, market intelligence and operational efficiency.
Learn MoreOngoing subscription with senior consultant hours and a training program included, so your team can solve statistical problems without a new procurement process for every request.
Learn MoreOngoing subscription for complete statistical support to your team
A senior consultant available to your team
Online and on-site training
The training program is included in the package
Software built by Estatística Digital for statistical work in regulated environments.
Turns FDA and ANVISA guidance into guided workflows: you start from the regulatory decision, the statistics run underneath, and every result comes with the justification your reviewers and regulators will read. IVPT pivotal study design available; stability in development.
Explore GuidanceStatAI consulting agent for pharma statistics
Answers questions on regulatory requirements citing the sources it used, is trained on the client's document base, and declines critical decisions without human review.
Learn moreAutomated Continued Process Verification
CPV platform with standardized preparation and an implementation fitted to each client's process.
Learn moreWe work at every stage of the pharmaceutical product lifecycle, offering tailored analyses and methodologies. Browse the use cases and see how we apply statistics to create value.
Experimental design and exploratory analysis to optimize compounds and processes.
Successful partnerships with leading companies in the pharmaceutical, biotechnology and medical device sectors
The Quality Control department needed to review its entire sampling scope — from raw material receipt to final batch release — without a standardized statistical framework that met global Quality Management guidelines.
We applied sampling methods based on ISO 2859 standards and ICH Q2 guidelines, along with process capability analyses, to build clear sampling rationales. We proposed adjustments to sample sizes and inspection levels that balance risk and operational efficiency, delivering a more robust sampling system aligned with GMP requirements and international audits.
The production team struggled to operationalize the Continued Process Verification (CPV) program within its daily routine, causing delays in report delivery and gaps in the control of critical parameters.
We assigned senior analysts to consolidate historical data and feed CPV protocols, developing risk-based action plans in line with ICH Q10. Together with Engineering, Quality and Operations, we revised the statistics Standard Operating Procedure (SOP), redefined the critical parameters and adjusted the frequency and techniques of data collection and analysis (SPC, data automation). The CPV program was rolled out smoothly, with clear and auditable workflows.
The team spent much of its effort on manual data collection, processing and formatting for Periodic Product Review reports, which limited the time available for critical performance analysis and optimization of statistical parameters.
We redesigned the analysis framework (including Process Capability and SPC charts) and implemented automation tools for data processing. With ongoing support from ED in generating and visualizing results, the team could focus on interpreting and refining the analyses, making the workflow faster and focused on high-value insights.
The client ran stability studies under multiple conditions (temperature, humidity, photostability) without a standardized statistical routine, resulting in inconsistent reports and risks in setting shelf life. It was hard to identify degradation trends and to distinguish normal variation from outliers that required investigation.
ED structured a periodic monitoring program that included: data collection protocols and sampling frequency aligned with ICH Q1A guidelines; linear and nonlinear regression analyses to estimate degradation curves and predict shelf life with confidence intervals; automated statistical reports, with trend control dashboards and outlier alerts to support the validation team; and customized training to enable analysts to interpret results and produce reports aligned with regulatory audits.
Facing an increase in unannounced inspections by the FDA and other agencies, the client had no structured process to prioritize stakeholders, gather critical documentation and make data available in real time. This caused delays in responding to observations and a risk of serious nonconformances.
ED developed an Inspection Readiness framework that included: mapping critical processes and identifying the owners (SMEs) for each audit workflow; checklists and data templates for audit responses, ensuring continuous access; pre-audit routines and periodic drills, with mock questioning and statistical performance reports; and on-demand consulting for immediate adjustments in case of findings, with statistical analyses and structured conclusions. The team now has a defined path to gather evidence and answer questions, instead of building each response from scratch.
Estatística Digital was founded by bringing together deep statistical knowledge and expertise in regulated environments to offer solutions that meet the most demanding requirements of the healthcare industry.
Our team is made up of professionals with extensive experience in applied statistics, computerized system validation, data science and regulatory compliance in GxP environments.
We work with pharmaceutical, biotechnology and medical device companies, providing statistical solutions that ensure quality, compliance and operational efficiency.
To turn data into reliable statistical decisions for regulated environments, contributing to the safe and effective development of products that impact people's health and well-being.
To be a reference in statistical solutions for regulated industries, combining scientific rigor and technological innovation to raise the sector's quality and compliance standards.
Get in touch to find out how we can help you optimize your statistical processes