Six Phases. One Comprehensive Approach.
The pharmaceutical industry is facing unprecedented challenges: growing regulatory complexity, tighter timelines, and increasing pressure to guarantee quality and compliance at every step. In this context, fragmentation between development, validation, and production often results in inefficiencies and risks.
To address these challenges, Qualipharma and PTM Consulting are proud to announce a strategic collaboration. More than a commercial alliance, this partnership represents the integration of visions and expertise to offer clients a seamless, end-to-end solution that transforms the way pharmaceutical processes are designed, validated, and controlled.
This collaboration combines complementary strengths. PTM Consulting brings proven expertise in product development, Quality by Design (QbD), risk management, and design control, while Qualipharma contributes solid capabilities in validation, commissioning and qualification, process controls, and GMP compliance. Together, they cover the entire product lifecycle, from concept and design to validation, production, and control. The result is less fragmentation, smoother processes, and proactive anticipation of risks.
The joint approach is structured around six key phases:
- QbD Process Development / Technology Transfer
- URS Definition
- Design Qualification (DQ) and Design Risk Analysis
- Commissioning and Qualification (IQ/OQ/PQ)
- Process Risk Analysis and Risk-Based Validation
- Statistical Process Control (SPC)
This is not an additional service, but an integrated, continuous journey to ensure quality and compliance from the very first step.
“ For Qualipharma, this collaboration represents a natural evolution of our mission: helping the pharmaceutical industry ensure quality and compliance through innovation, expertise, and global reach. By joining forces with PTM, we are able to provide our clients with an end-to-end, integrated pathway that reduces complexity, anticipates risks, and accelerates time to market. Together, we are shaping a new standard of excellence for the sector.”— Gabriel Tallada, CEO – Qualipharma
“At PTM, we have always believed in the value of partnerships that bring together complementary expertise to create truly integrated solutions. Our collaboration with Qualipharma allows us to offer the market an innovative approach that supports pharmaceutical development from concept to full compliance. We are especially committed to addressing not only the explicit needs of our clients, but also those that are still unspoken. This is a significant step forward in proposing a new way of delivering services – with vision, flexibility, and real-world effectiveness.” — Paolo Mazzoni, CEO – PTM Consulting
Upcoming Key events
The collaboration will be presented to the industry during key events: Farmaforum (Madrid, 17–18 September) and ISPE Pharma 4.0 & Annex 1 Conference (Barcelona, 9-10 December). These milestones will serve as opportunities to showcase concrete examples of this integrated approach in action.
Two countries, one shared standard, one commitment to excellence. With this collaboration, Qualipharma and PTM Consulting reaffirm their mission: to establish a new global reference for integrated pharmaceutical support, ensuring quality from concept to commercialization.
