JMA Plan Ecosystem

Integrated solutions for regulated operations

Connected expertise to turn pharmaceutical projects into operational excellence. JMA Plan brings together engineering, consulting, technology, people and regulatory knowledge to support companies in the pharmaceutical and Life Sciences industries at every stage of the journey — from project concept to start-up and the continuous improvement of operations.

Project Management
Internal Audits
GxP Compliance
Technical Documentation

Engineering

End-to-end projects

We offer complete engineering services for pharmaceutical facilities, from concept to final handover, always in compliance with current regulatory standards.

Design of new facilities and renovations
Facility qualification (IQ, OQ, PQ)
Construction project management
Compliance with ANVISA and FDA standards
Cleanroom and controlled area design
Construction site management and technical supervision

Outsourcing

Qualified professionals

We provide specialized professionals to join our clients' teams, maintaining regulatory compliance and ensuring operational continuity.

Placement of pharmacists and engineers
Management of quality and regulatory departments
Temporary support for specific projects
Dedicated or shared teams
GxP-qualified professionals
Vacation and leave coverage

Consulting

Strategic advisory

Our experienced consultants provide technical and strategic advice to help your company navigate the complex pharmaceutical regulatory environment.

Compliance and data integrity audits
Supplier audits
Technical and regulatory due diligence
Remediation action planning
Risk assessment and gap analysis
Regulatory inspection support

Validation

Full lifecycle

We develop and execute all the documentation required throughout the validation lifecycle, ensuring compliance with regulatory requirements.

Process and analytical method validation
Computerized system validation (CSV)
Equipment qualification
Cleaning validation
Stability studies
Change control

Information Technology

Regulated systems

We implement and validate IT solutions for regulated environments, ensuring data integrity and compliance with ANVISA requirements and FDA 21 CFR Part 11.

Pharmaceutical ERP implementation
Computerized system validation
Data integrity (ALCOA+)
LIMS and QMS systems
Infrastructure for GxP environments
Electronic document management

Training

Specialized training

We develop customized training programs that build team capabilities across a wide range of Good Practice topics in the pharmaceutical sector.

GMP, GDP, GLP, GCP and GVP
Custom in-house programs
Internal auditor qualification
Regulatory training
Specialized workshops and seminars
E-learning and hybrid formats

Which solution does your company need?

Our team is ready to understand your challenges and propose the most suitable solution for your business.

Talk to a specialist