About DRP
We don't work for the industry. We are part of it.
DRP Assurance was founded by professionals who spent years in production, quality control, quality assurance, validation and IT at pharmaceutical laboratories. We know the questions an inspector asks because we have sat on the other side of the table.
Origin
We come from the same place you do.
To understand such a highly regulated industry you have to know its processes from the inside: the requirements, the constraints and the room for improvement. You don't learn that from a manual.
That is why our proposals actually work. We know what happens on a Monday morning on the plant floor, what an inspector will ask, and which document nobody will ever read. We design for the first two. The third, we avoid.
Areas we have worked in
- Production
- Quality Control
- Quality Assurance
- Validation
- Biotech processes
- Engineering and Maintenance
- IT and user support
- FAT and SAT verification
- +20years working inside the pharmaceutical industry
- 8service lines, from the supplier's factory to the software that automates
- 47concrete capabilities in our service catalog
- 4reference authorities: ANMAT, ANVISA, EMA and FDA
#SomosPharma
Pharmaceutical industry. Experience from the inside.
We don't work for the pharmaceutical industry: we are part of it. We've worked in production, quality control, quality assurance, IT and validation. That's why we design solutions that work on Monday morning, not just on inspection day.
What sets us apart
Why DRP.
Four reasons Quality and IT teams choose us, and keep choosing us.
Real-world experience
More than 20 years working in the pharmaceutical industry. We know the processes as users, as auditors and as technical specialists.
Pragmatic approach
No textbook solutions. Validation effort is scaled to the actual risk of each system, process or area.
360° view
Quality, IT, production and engineering at the same table. We translate regulations into the language of each department.
Real knowledge transfer
Your team is trained to maintain the validated state. We don't create dependency: we leave knowledge behind.
Method
How we work
Five steps we follow on every project, whether it is a system, a spreadsheet, a cleanroom or a procedure.
- 01
Understand
We assess the process, system or area with the people who use it. Before writing a single document, we understand how the work actually gets done.
- 02
Assess the risk
We apply ICH Q9 to decide where the effort should go. Validating everything with the same intensity is expensive and adds no safety.
- 03
Design the strategy
We define scope, deliverables, acceptance criteria and owners. Everything is agreed before execution starts.
- 04
Execute with evidence
Protocols, tests and records with full traceability. Every conclusion rests on objective evidence.
- 05
Transfer and sustain
Final report, training and a plan to maintain the validated state when something changes.
Team
Four directors, one shared view.
A deliberately small team: the people who assess are the people who execute, and whoever signs the report knows every detail of the project.
- 01
Managing Director and Operations
Strategy, project planning and the relationship with every client.
- 02
Quality Director
GMP judgment, risk management and regulatory review of every deliverable.
- 03
Technology Director
Computerized systems, infrastructure, data integrity and continuity.
- 04
Innovation and Communications Director
In-house tools, training and knowledge sharing.
Standards
We work to international standards.
Our own operations are aligned with quality, information security and business continuity standards. For each client we apply the framework their market requires.
International
- ISO 9001
- ISO/IEC 27001
- ISO 22301
- EU GMP Annex 11
- PIC/S
- 21 CFR Part 11
- GAMP 5
- ICH Q9 · Q10
Regional authorities
- ANMAT (Argentina)
- ANVISA (Brazil)
- COFEPRIS (Mexico)
- INVIMA (Colombia)
- APEMEC
Commitment
Responsibility that goes further.
We are part of an industry that protects the health of millions of people. Every validation, every optimized process and every improvement helps safe and effective medicines reach the people who need them.
Ethics and transparency
We operate with integrity on every project. Our processes are clear, documented and auditable, because transparency is also a responsibility we owe the industry.
- Documented, auditable processes
- Open, shared methodologies
- Rigorous ethical standards
Environmental commitment
We choose digital processes, electronic documentation and deliverables that minimize the use of paper and physical resources. We call it Green Assurance.
- 100% digital validations
- Electronic signatures on documents
- Green Assurance: active sustainability
Equity and respect
We foster an inclusive, collaborative environment. Diverse perspectives are an essential part of critical thinking. Every person counts, every voice adds value.
- Diverse, inclusive teams
- Safe spaces for dialogue
- Critical thinking is valued
Next step
Want to work with a team
that understands your industry?
We are DRP Assurance. Somos Pharma. Tell us your challenge and let's work on it together.