capabilities

Water system SME, WFI, RO, DI, lab water purification units

Hydro BioTechnology is the water systems component of Storm Biotechnology.  Hydro BioTechnology has expertise in all pharmaceutical water systems and can recommend which system will best fit your needs.  Hydro BioTechnology can also qualify and maintain a brand new water system or your current water system.    

cGMP manufacturing, understanding of all aspects and required regulations from pre-clinical through commercial approval

With 30 years of experience in a regulated environment in both the US and EU Storm Biotechnology has the knowledge and understanding of the past, present and the future trends of cGMP, FDA/EMEA. 

503B expertise 

Storm Biotechnology has worked with and helped many 503 registered facilities bring their CGMP inline with the FDA’s expectations for this space.

FDA/EMEA compliance expertise, mock audits, mock audit coaching, and FDA preparation audits

Storm Biotechnology will share knowledge from extensive FDA audit experience with your organization and your team. Storm Biotechnology can provide FDA style mock audits that can include “time-outs” for coaching and look at the best practices and actions in an FDA/EMEA audit. From our audit we can provide your team with a road map of categorized corrective actions that will ensure a more successful future audit.  

Annual cGMP training 

Storm Biotechnology can provide annual cGMP training for your entire staff.    

Design build oversite (for proper operational aspects and compliance to required design regulations) including all aspects of post construction qualifications and startup operations and documentation

Storm Biotechnology has extensive experience in design build. Our hands-on experience in the production space enables us to ensure that your process flows and your design will meet best practices and industry standards. Storm Biotechnology can also be part of your start up staff and ensure all qualification documentation is executed. Storm Biotechnology can also provide you with the SOPs and batch Production records to get your process started.       

IQ/OQ/PQ for all critical equipment and systems

Storm Biotechnology can perform installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) on your new critical systems:  autoclaves, water systems, ovens, clean rooms, fill lines, etc.   Storm Biotechnology can also perform retrospective calcifications as required.  

All facets of facility support: calibration, maintenance programs, equipment file generation

Storm Biotechnology can review your current engineering, maintenance, and facilities documentation to ensure it meets current compliance expectations and provide solutions for any gaps in your programs.  

Process validation

Storm Biotechnology can review your current process validation against real time processes to ensure compliance.  Storm Biotechnology can also help you increase your batch sizes and provide process validation support to this goal.

And a lot more

Contact us!