We help you ensure stage-appropriate compliance systems so your program stays aligned with “Quality by Design” principals and ahead of the curve – without wasting resources, capital, or generating excessive bureaucracy.
QMS Design:
We help you develop a Quality Management System (QMS) that meets the unique needs of your program and stage of development.
QMS Gap Assessment:
We analyze your existing QMS, identify any gaps, and provide stage appropriate and resource efficient solutions to address those gaps.
Document authoring, review and revision:
We write your SOPs, policies, and other controlled documents, or provide expert review and revision of existing documents.
Supplier Oversight:
We perform risk assessments and/or audits of critical raw material suppliers, contract manufacturers and analytical service providers to ensure their quality standards are aligned with your needs.
Audits: both in-person and virtual options:
Historically, audits are done on-site and in person. However, due to our clients’ needs during the CoVID-19 global pandemic, we’ve built a new offering: the Virtual Remote Audit. Take a look at this flyer for more information and put in a request for a consultation if this might be a fit for you as you work to move your program forward in these unusual times.
We help you ensure stage-appropriate compliance systems so your program stays aligned with “Quality by Design” principals and ahead of the curve – without wasting resources, capital, or generating excessive bureaucracy.
QMS Design:
We help you develop a Quality Management System (QMS) that meets the unique needs of your program and stage of development.
QMS Gap Assessment:
We analyze your existing QMS, identify any gaps, and provide stage appropriate and resource efficient solutions to address those gaps.
Document authoring, review and revision:
We write your SOPs, policies, and other controlled documents, or provide expert review and revision of existing documents.
Supplier Oversight:
We perform risk assessments and/or audits of critical raw material suppliers, contract manufacturers and analytical service providers to ensure their quality standards are aligned with your needs.
Audits: both in-person and virtual options:
Historically, audits are done on-site and in person. However, due to our clients’ needs during the CoVID-19 global pandemic, we’ve built a new offering: the Virtual Remote Audit. Take a look at this flyer for more information and put in a request for a consultation if this might be a fit for you as you work to move your program forward in these unusual times.