Services

Quality and Compliance

To address the Quality systems complexity and their ongoing dynamics, Complyomics approaches

Quality as a Continuum.

Become full confident in your productive and effective Quality management:

- Compliant with global regulatory standards (GxP).

- Scalable across your company /product development.

- Built for long-term sustainability and audit readiness.

Design and deployment of Quality Management Systems (QMS)
Preparation of the QMS related documents (Quality Manual, SOPs, Site Master File, ...)
Inspection and Certification readiness
Trainings (Quality Standards regulations (GxP), Audit conduct, SOP preparation, ...)

External Quality Assurance

Our externalized Quality Assurance solutions ensure an incremental dimensioning adjusted to your needs.

To support organizations with an efficient and cost-effective QA function we propose

4 pre-defined External Quality Assurance packages:

For Start-up or
small size biotech
seeking to start their
Quality journey.

For organizations committed to Quality management
aiming for advanced
best practices,
to be recognized
as premium player.

For organizations required
to comply with
GxP regulations
and wishing successful Regulatory Authorities inspections.

For organizations with a temporary QA resource gap
and needing
immediate solution.

Bioanalytical Solutions

We support the development of appropriate bioanalytical strategies and their associated assays,

adapting to the progression of your product.
Our services span from non-regulated assay development to comprehensive GxP validation,

ensuring support for your GLP and GCP studies with a strong focus on Biotherapeutics.

We provide tailored training on specific topics:

GxP method validation, Assay trouble-shooting, Assay formats for different biotherapeutic modalities, ...

Fit for purpose assay development and validation

Monitoring of assay robustness

Selection and qualification of CROs

Oversight of
sample analysis

Quality Audits

We offer audits - encompassing systems, facilities, processes and studies - aligned with GxP Standards such as:

Good Laboratory Practice (GLP)

Good Manufacturing Practice (GMP)

Good Clinical Laboratory Practice (GCLP)

Good Documentation Practice, ALCOA+

Services

Quality and Compliance

Design and deployment of Quality Management Systems (QMS)
Preparation of the QMS related documents (Quality Manual, SOPs, Site Master File, ...)
Inspection and Certification readiness
Trainings (Quality Standards regulations (GxP), Audit conduct, SOP preparation, ...)

External Quality Assurance

For Start-up or
small size biotech
seeking to start their
Quality journey.

For organizations committed to Quality management
aiming for advanced
best practices,
to be recognized
as premium player.

For organizations required
to comply with
GxP regulations
and wishing successful Regulatory Authorities inspections.

For organizations with a temporary QA resource gap
and needing
immediate solution.

Bioanalytical Solutions

Fit for purpose assay development and validation

Monitoring of assay robustness

Selection and qualification of CROs

Oversight of
sample analysis

Quality Audits

Systematic, independent and documented audit process
conducted by Certified Quality Auditor from American Society for Quality (ASQ).

Main menu

Services

Quality and Compliance

Design and deployment of Quality Management Systems (QMS)Preparation of the QMS related documents (Quality Manual, SOPs, Site Master File, ...)Inspection and Certification readinessTrainings (Quality Standards regulations (GxP), Audit conduct, SOP preparation, ...)

External Quality Assurance

For Start-up or small size biotech seeking to start theirQuality journey.

For organizations committed to Quality management aiming for advanced best practices,to be recognized as premium player.

For organizations required to comply with GxP regulations and wishing successful Regulatory Authorities inspections.

For organizations with a temporary QA resource gap and needing immediate solution.

Bioanalytical Solutions

Fit for purpose assay development and validation

Monitoring of assay robustness

Selection and qualification of CROs

Oversight of sample analysis

Quality Audits

Systematic, independent and documented audit processconducted by Certified Quality Auditor from American Society for Quality (ASQ).

Design and deployment of Quality Management Systems (QMS)
Preparation of the QMS related documents (Quality Manual, SOPs, Site Master File, ...)
Inspection and Certification readiness
Trainings (Quality Standards regulations (GxP), Audit conduct, SOP preparation, ...)

For Start-up or
small size biotech
seeking to start their
Quality journey.

For organizations committed to Quality management
aiming for advanced
best practices,
to be recognized
as premium player.

For organizations required
to comply with
GxP regulations
and wishing successful Regulatory Authorities inspections.

For organizations with a temporary QA resource gap
and needing
immediate solution.

Oversight of
sample analysis

Systematic, independent and documented audit process
conducted by Certified Quality Auditor from American Society for Quality (ASQ).