Reliability Engineering
We can provide reliability engineering and complete design for reliability (DFR) solutions as appropriate. The Design for Reliability Model below illustrates its integration with 5 stage Product Development Process.Service and Excellence
Our mantra is “excellence”.We support our clients in achieving success right from beginning of engagement through implementation and delivery. Although each project is different we employ some basic principles to achieve success. We ensure: Our mantra is “excellence”.
We support our clients in achieving success right from beginning of engagement through implementation and delivery.
Although each project is different we employ some basic principles to achieve success.
We ensure:
- that we align ourselves with our client’s ultimate goal/business objective
- engage right resources
- risk mitigation
- issue resolution
- transparency
- quality standards
- timely deliverable
Quality
We have thorough expertise in implementing industry appropriate Quality Systems- Six Sigma
- Design for Six Sigma
- Chemical Design for Six Sigma for Pharmaceutical Industry
- Biostatistics
Regulatory and compliance
A successful clinical and regulatory strategy should never rule out creativity.We can assist with all aspects of regulatory affairs
Regulatory Capabilities
- Global regulatory strategy
- Pre-IDE/IND FDA meetings and applications
- 510(k), PMA, and NDA submissions
- CE Mark TF/STED/Dossier
- Import/export certification
- FAA
- FDA
- CE
- CMMI
- DCGI (India)
- ISO