Compliance and Validation Consulting
Bridges the gap between clients, manufacturing processes and regulatory challenges.
DOC excels in providing top-tier consultancy, qualification, and validation services, focusing on both processes and systems for the global biopharmaceutical industry, including CMOs and OEMs. We don't just offer services; we deliver comprehensive solutions that address the complex needs of our clients.
As an innovative communication platform, DOC bridges the gap between our customers' operational needs and cGMP compliance requirements. We act as a pivotal system integrator, ensuring that your processes and systems meet and exceed the stringent standards set by regulatory authorities.
Our expertise extends beyond service delivery. We immerse ourselves in understanding your specific challenges and objectives, providing tailored solutions that enhance efficiency, reliability, and compliance. Whether you're navigating the intricacies of process validation or system qualification, DOC is your long-term partner, offering a blend of technical expertise and strategic insight.
With DOC, you gain access to a team committed to ensuring your success in the highly regulated biopharmaceutical landscape. We empower our clients with knowledge, innovative solutions, and unwavering support, driving progress and fostering excellence in every aspect of their operations. Partner with DOC to transform your compliance journey into a strategic asset.
Facts:
- History of more than 25 years as one of the Italian forerunners for consultancy, qualification and validation as a service.
Advanced technical know-how to support OEM compliance with GMP.
Continuous access to instrumentation and laboratories.
Continuously exchanging expertise with regulatory agencies through internationally recognized association events.
Sharing knowledge through training for clients and new talent with national educational programs.
Integrated with other Masco Group competences and laboratories globally.
Our Expertise:
A.P.I. Area:
A.P.I. Synthesis Reactors
Centrifuges
Filter dryers
Static dryers
Freeze-dryers
Bulk flu vaccine process equipment
Finished pharmaceuticals:
HVAC and clean rooms
Steam autoclaves
Dry-heat oven
Filling lines for injectables
Lyophilizer
Oral solids manufacturing equipment
Pharma water and steam systems
Solution preparation systems
Engineering:
Conceptual design
GMP review
Design qualification
GMP Compliance and Validation:
Validation master plan
User requirements specification preparation
Quality risk management in compliance with ICHQ9
Traceability matrix preparation
Validation protocols preparation (IQ, OQ, PQ, PV)
Computerized control system validation as per GAMP and 21 CFR
Process Validation:
Sterilizing Filter Validation
Compatibility, Extractables and Leachables on plastic process components
Particle release test
Toxicological assessment
Process optimisation
Container closure test
Sanitizing efficacy validation
