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

For more information, please contact:

Manfredi