Do you want a more agile, secure and compliant pharma?

We transform your pharmaceutical operation into a validated, traceable and scalable digital ecosystemaligned with FDA, EMA and COFEPRIS regulations.

Assess the maturity of your regulated infrastructure

REDUCTION OF ERRORS IN PHARMACOVIGILANCE

FEWER CRITICAL AUDIT FINDINGS

HOURS FOR REGULATORY REPORTING (PREVIOUSLY WEEKS)

BATCH-TO-BATCH TRACEABILITY

Manufacturers and Technologies

At Scanda Group we work with leading global manufacturers, integrating validated technology with our consultancy to guarantee regulatory compliance, batch-to-batch traceability and critical continuity:

Azure, Power Platform and Power BI for integrate LIMS, ERP and clinical trialsautomating regulatory flows.

Modern Data Warehouse that integrates ERP, MES and LIMS with traceability and reliable real-time reporting.

Validated cloud infrastructure GxP with scalability, high availability and regulatory compliance.

Secure platform for advanced analytics and ML in pharmacovigilanceby streamlining regulatory audits.

Dell APEX provides validated infrastructure GxP for backups, secure storage and business continuity.

Endpoint and access management that ensures that only validated users interact with critical data.

Perimeter and Cloud Security forprotecting sensitive data and pharmaceutical supply chain.

GRC platform foraudit traceability, document control and FDA / EMA / COFEPRIS compliance.

Genesys Cloud CX enables a secure omnichannel ecosystem with chatbots and traceability in pharmacovigilance.

With these alliances we ensure that each project complies with international standards and accelerates innovation throughout the value chain.

CHALLENGES

AND HOW WE SOLVE THEM

In the pharmaceutical industry, the difference between complying and being out of the market is measured by hours, traceability and audits without critical findings.

We guarantee continuity and compliance of the operation.

➤ ChallengesCritical plants without high availability, recurring audit findings, risk of clinical data loss.

- Services: Hybrid Cloud with Microsoft/AWS/Huawei/Google/Dell; BaaS validated GxP with Dell APEX; Identity Governance & GRC with Fortinet/Ivanti/Archer; IT SecOps Automation for clinical trials.
- Benefits: 24/7 continuity, -45% critical findings, increased regulatory confidence.

Are you prepared for your next FDA inspection or will you again duplicate processes to cover audits?

AGENDA A STRATEGY SESSION

Ensuring traceability and governance of pharmaceutical data

➤ Challenges: Batches without digital traceability, fragmented ERP/MES/LIMS data, risk of non-compliance with FDA/EMA/COFEPRIS.

- Services: Critical data integration; validated Data Governance; modern Data Warehouse (Azure/Snowflake/Google Cloud); AI applied to pharmacovigilance.
- Benefits: 60% less audit preparation time, greater reliability in regulatory reporting.

Does each lot and clinical report have reliable 100% traceability to an inspection?

TALK TO A PHARMACEUTICAL EXPERT

Connecting patients, physicians and partners

➤ Challenges: Disparate interactions with physicians, distributors and patients; inefficient regulated training; slow pharmacovigilance.

- Services: Genesys Cloud CX for omnichannel; Nexthink/Quest/Parallels for Digital Employee Experience; eLearning and LMS for GMP/GxP; Virtual Agents & Chatbots; Hyperautomation with Power Platform.
- Benefits: -70% reporting errors, +100% traceability, increased physician and patient satisfaction.

Do your clinical and medical teams work with modern tools or with manual processes that generate regulatory risk?

AGENDA A STRATEGY SESSION

WHAT WE DO AND HOW WE DO IT

Consultative and scalable methodology:

What we do

Case studies demonstrating plant and supply chain impact.

Continuity and compliance 24/7

Infrastructure and storage validated GxP for plants and cold chain; critical backups and high availability.

Case: Validated infrastructure GxP reduced 45% findings in international audits.

Traceability and data governance

We consolidate ERP, MES and LIMS in a modern Data Warehouse with validated governance for FDA/EMA/COFEPRIS audits.

Case: Validated Data Warehouse consolidated ERP/MES/LIMS and reduced 60% audit preparation time.

Omnichannel experience with physicians and patients

Genesys Cloud CX + bots for safe care, traceability lot by lot and pharmacovigilance automation.

Case: -70% errors in reporting and traceability 100% in regulated interactions.

How do we do it?

Validated methodology for the pharmaceutical industry: Regulatory and technological assessment → Validated architecture design → Controlled implementation → Operation and continuous improvement.

Regulatory and technological assessment

We evaluate compliance with FDA, EMA and COFEPRIS, as well as the technological maturity of the operation.
Validated architecture design

We defined the architecture under GxP standards and regulatory validation best practices.
Controlled implementation

We deploy validated solutions, with full test traceability and regulatory documentation.
Operation and continuous improvement

We monitor the operation under compliance, ensuring successful audits and constant evolution.

Stages: Regulatory and technological assessment, Validated architecture design, Controlled implementation, Operation and continuous improvement.

SUCCESS CASES

At Scanda Group we have helped pharmaceutical companies comply with global regulations while modernizing their operations. The results are tangible: audits with no critical findings, regulatory reporting in record time and safe experiences for physicians and patients.

From manual pharmacovigilance to automated reporting

A regional laboratory took weeks to consolidate reports of adverse effects. With a Data Lake in Azure and automation in Power Platform, reduced the reporting time to COFEPRIS from 15 days to 48 hours.

Results: Timely compliance, -70% human error, organizational confidence in regulatory decisions.

In the words of our client:

"Our challenge was not just to digitize, it was to comply with international regulations. With Scanda we achieved batch-to-batch traceability and audits without critical findings, while speeding products to market."
- CIO of Latin American pharmaceutical company

TRANSFORM YOUR BUSINESS

RESULTS THAT ADD UP

With Grupo Scanda, pharmaceutical companies leave behind fragmented systems and manual processes that delay audits, to evolve towards digital, traceable and permanently compliant operations.

Before:

Fragmented systems that duplicate processes

Delays in regulatory audits

Low visibility in cold chain

Clinical reports late

Then with Scanda:

24/7 continuity in plants and cold chain

-45% critical findings in audits

Regulatory reports on 48 hours

+100% traceability lot by lot

Why us?

At Scanda Group we understand that in the pharmaceutical sector, technology must not only enable efficiency, but also strict compliance and full traceability. We do not offer isolated solutions, but validated digital ecosystems that ensure successful audits, reduce risks and accelerate new products to market.