i3 infotek excels at validation engineering services.

Specifications and procedures are validated at each stage to demonstrate that your manufactured product satisfies regulatory safety and efficacy criteria. Our validation specialists take great pride in perfecting the production process while adhering to all governance and industry laws. Our knowledge ensures that you can continuously offer high-quality products while being compliant.

How do we ensure you receive nothing but the best?

Our validation service engineers supervise and direct the production process, systems, and equipment to craft the finished product. For extensive levels of validation following industry best practices and quality standards, thorough, rigorous processes are put in place. We ensure ideal production equipment calibrations, settings, and durations this way.

To accelerate the next validation engineering project, consider our services.

Validation strategy and coordinated activities for major projects
Project management of a validation engineering initiative (in-house or ours)
Leading cross-functional SMEs in validation activities and change management
Create, review, and approve documentation across disciplines for regulatory submission or response
Direct and oversee all outsourced validation assignments

Plan and accelerate your next validation engineering project with i3 infotek.

Key Industry Focus

Bringing a new medicine to market necessitates several safety and risk management measures at every stage. Clinical data, adverse event reporting, and manufacturing specifics require skilled planning and execution. i3 infotek has highly qualified validation engineering service professionals ready to assist you with manufacturing your biotech or pharmaceutical product. Consultants at i3 infotek are degreed professionals in the pharmaceutical and associated chemical and biological fields.Our versatile validation engineers provide the following:

Development of RA strategy and work plan
Preparation of complete registration casebook for internal approval and timely submissions
Liaise between regulatory bodies and the company for registration, sample assessment, regulator inquiries, review committee sessions
Expedite the registration process
Create, document, and maintain a complete file
Schedule and Resource Allocation (for software verification and validation activities)
Develop and prepare SOPs and post-launch procedures
Inform and train in-house staff for ongoing product compliance.

Our validation professionals assist with medical device engineering, regulation, and compliance. We have helped several medical device firms launch their products faster by providing expert guidance. We can assist with everything from design engineering to post-launch monitoring. In this manner, your company benefits from hiring the appropriate engineers and professionals.

Complex medical device design specifications can bring up practical difficulties. We provide DFMEA/PFMEA expertise to assist you in producing a compliant, validated medical device. i3 infotek consultants frequently help with the following:

Design and perform FMEA and other aspects of risk analysis
Audit Services and GAP Assessments
Increase protection against unwanted surprises in production
Document known risks and associated mitigating actions already in place

Validation Engineering

Everyone needs a little validation. Or a lot.

Key Industry Focus

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