Services

TheQ offers a wide range of services to support your needs.

Using a risk-based approach, our team of experts is committed to helping you navigate the intricacies of the GxP regulations.

Supplier Management Anchor

Supplier Auditing & Management

TheQ can help you assure the control of outsourced activities, through:

Compliance auditing, designed to assess and ensure the suitability, competency, and performance of your GxP suppliers.
Establishment and implementation of Quality Agreements to ensure delineation of responsibilities and communication expectations; as well as, to ensure outsourced activities are carried out in accordance with applicable regulations.
Review and assessment of records and results related to outsourced activities to ensure compliance.

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Quality Assurance Anchor

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Quality Assurance (QA)

TheQ can serve as your interim Head of QA or provide general QA support to ensure your quality systems are GxP-compliant and appropriate for your stage of development.

Areas of expertise include:

Gap assessments
Development, implementation, and management of quality systems
Electronic quality management systems
Compliance reviews of batch records, quality events, protocols, reports, etc.
Inspection readiness
Internal audits
Training

Quality Control Anchor

Quality Control (QC)

TheQ can provide interim QC support to establish and/or maintain appropriate procedures and specifications to assure your product's safety, identity, strength, quality, and purity.

Our QC support services, include:

Establishment and implementation of QC procedures, such as material specifications, data review, stability programs, etc.
Technical reviews of method validations, release data, stability records, etc.

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Regulatory CMC Anchor

Regulatory CMC

From authoring to reviewing regulatory submission content, TheQ can provide the expertise you need to ensure successful IND, NDA, and global submissions.

Our regulatory offerings, include:

eCTD support
Module 2 and 3 Drug Substance and Drug Product sections
Review and data verification to ensure submission accuracy
Organization of CMC files and source documents

Other Services

TheQ's network of consultants can also offer expertise in:

Microbiology
Facilities/Equipment
Process Validation

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