Departments
Health Records
Health registration in Peru is a complex process that requires the submission of technical documentation, laboratory testing, and payment of fees. DIGEMID is the entity responsible for evaluating and authorizing the marketing of pharmaceutical products, medical devices, and other health-related products.
Training Courses
Training courses are educational programs designed to provide specific knowledge, skills, and competencies in a specific area. In the context of the pharmaceutical and medical industry, training courses can cover a variety of topics,
Imports.
Customs services in drugstores and laboratories refer to the management and coordination of the import and export of pharmaceutical products, medical devices, and healthcare products, in compliance with applicable customs and health regulations and standards.
Regulatory Representation
Regulatory Representation refers to the action of representing and defending the interests of a company or organization before regulatory authorities and government agencies, in order to ensure compliance with applicable rules and regulations.
Pharmaceutical consulting for companies refers to the provision of specialized consulting and advisory services in the pharmaceutical industry. These services are designed to help pharmaceutical and related companies navigate complex regulatory requirements, improve their performance, and achieve their goals.
Certifications.
Pharmaceutical company certifications in Peru are official documents that certify that a pharmaceutical company complies with certain standards, norms, or regulations established by recognized authorities in the Peruvian pharmaceutical industry.
Translations
Dossier translations refer to the process of translating health and medical documents and texts from one language to another while maintaining the accuracy and integrity of the original content.
Quality Management
Quality management is a systematic and structured approach to ensuring that an organization's products or services meet the requirements and expectations of customers and other interested parties.
Logistics Services.
Logistics services in Peru refer to the management and coordination of the supply chain, from production to the final delivery of products and goods to customers.
Pharmacovigilance.
Pharmacovigilance is the science and activity related to the detection, evaluation, understanding, and prevention of adverse drug effects. Its objective is to identify and mitigate the risks associated with the use of medications and improve patient safety.
Technovigilance.
Technovigilance is the activity related to the detection, assessment, understanding, and prevention of adverse events involving medical devices. Its objective is to identify and mitigate the risks associated with the use of medical devices and improve patient safety.
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Mobile Pharmacovigilance Application
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Pharmacovigilance and Technovigilance Hosting Service
Database
(Novi-Farma-DB)
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Pharmacovigilance
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Technological surveillance
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Novi-Farma-DB: Comprehensive Pharmacovigilance and Technovigilance Platform
Description:
Novi-Farma-DB is an advanced system designed for the efficient and safe management of adverse events in medications (pharmacovigilance) and medical devices (technovigilance), complying with the regulatory standards of DIGEMID (Peru), FDA (USA) and AEMPS (EU).
🔹 Key Implementations:
Multi-company and Multi-user Management
Access segregated by company and roles (e.g. administrator, reporter, auditor).
Permission control for editing/consulting sensitive fields.
Automated Regulatory Compliance
Automatic notification to DIGEMID, FDA (21 CFR Part 11) and EudraVigilance (EU).
Integrated MedDRA and ICD-10 coding for term standardization.
Electronic signatures with OTP and blockchain for tamper-evident validation.
Complete Traceability
Audit Trail: Change log with IP, user and timestamp.
Unique case numbering: FV-INICIALES_EMP-000001 (6+ digits).
AES-256 encryption for sensitive data (patient initials only).
Advanced Integrations
Connected APIs:
DIGEMID (medication consultation).
MedDRA (standardized terminology).
ICD-10 (diagnosis classification).
Digital forms:
Adaptation of the DIGEMID 032-2017 format for reports.
Downloadable templates for telephone or written cases.
Analytics and Reports
Interactive dashboards: Annual trends, concomitance and cumulative charts.
Proactive alerts: Detection of patterns and critical deadlines (e.g. notification in <72h).
AI Assistant
Integrated chatbot for questions about regulations, deadlines, or processes.
Automatic classification of adverse events based on NLP.
Secure Portal
Restricted access: Login with multi-factor authentication (MFA).
Documentation module: SOPs, regulatory guides, and certifications available.
🔗 Access URL:
https://www.novimedicalgroup.com/farmacovigilancia (requires credentials).
✅ Key Benefits:
Error reduction: Automation of 95% of manual processes.
Legal protection: Audited compliance and GDPR/DIGEMID encryption.
Multiplatform: Web access from any device.
"Ensuring security, traceability, and regulatory alignment in every report."
Need a demo? Contact us at gerencia@novimedicalgroup.com.
NoviMedical Data Management Systems
At NoviMedical, we have developed two specialized platforms to ensure regulatory compliance and intelligent document management:
1. Novi-Farma-DB: Pharmacovigilance and Technovigilance Databases
They are not drug databases, but rather systems for monitoring adverse events, technical incidents, and regulatory requirements.
Key implementations:
Automated recording of safety reports (ADRs, medical device complaints).
Smart alerts for compliance with deadlines (MDR, FDA, ANMAT, INVIMA).
Integration with AI for predictive risk analysis.
Workflows validated under ISO 13485, 21 CFR Part 11 and GDPR.
2. Novi-Datos-DB: Regulatory Documentation Portal
Centralized platform for managing technical files, certificates, and regulations.
Advanced Features:
AI-powered semantic search engine to locate documents by content, not just by name.
Secure PDF, Excel, and Word viewer with change traceability.
Automatic classification by document type, company and department (Regulatory, Quality, Tenders).
Complies with e-signature and encryption for confidential documents.
Both systems are designed for regulatory and compliance teams, eliminating the use of scattered files and ensuring successful audits.
Technology at the service of patient safety and operational excellence.
Advanced Regulatory Management and Pharmacovigilance Systems Novimedical Group SAC
Our Novi-Farma-DB (Pharmacovigilance/Technovigilance) and Novi-Datos-DB (Intelligent Document Portal) platforms integrate Artificial Intelligence to ensure global regulatory compliance (FDA, MDR, ANMAT, INVIMA, DIGEMID), optimizing the management of adverse events, technical incidents, and critical documentation.
🔍 Novi-Farma-DB
Pharmacovigilance & Technovigilance with AI.
Automated Detection: AI to identify patterns in adverse events and technical incidents, with real-time alerts.
Smart Reports: Automatic document generation for FDA, MDR, ANMAT, and other agencies, adapting to their protocols.
Global Integration: Connected with systems such as VigiFlow and EudraVigilance for regulatory notifications.
(It is not a drug database, but a risk and compliance management system.)
📂 Novi-Data-DB
Documentary Portal with Advanced AI.
Semantic Search: AI understands complex queries and retrieves relevant documents (reports, certifications, regulations).
Automatic Processing: Extraction of key data (batches, dates, requirements) from PDFs, Excel and Word.
Smart Classification: Organizes documents by regulations (FDA 21 CFR, MDR, ISO 13485) and regulatory categories.
⚙️ Key Implementations
Compliance Automation: AI verifies that documents meet the requirements of each agency (ANMAT, INVIMA, DIGEMID).
Assisted Audits: Automatic generation of evidence for inspections.
Security and Traceability: Role-based access (Regulatory, QA, Manufacturers) with blockchain-based change log.
Certification in Process:
Currently in the validation phase for FDA certification, complying with:
MDR (EU): Post-market surveillance of medical devices.
FDA 21 CFR: Adverse Event Reporting and Documentation Requirements.
Local Standards: Specific protocols from ANMAT (Argentina), INVIMA (Colombia) and DIGEMID (Peru).
Novimedical Group SAC
Technology and AI for a safe, efficient, and audited regulatory ecosystem.
Note: These platforms are not drug databases, but rather specialized systems for risk management, regulatory compliance, and regulatory documentation.