Quality Assurance

We help you ensure that phase-appropriate compliant systems are in place so your program stays aligned with “Quality by Design” principles 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 phase of development.

QMS gap assessment

We analyze your existing QMS, identify any gaps, and provide phase-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 evaluations, 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

The generation and execution of a comprehensive phase-appropriate audit program is critical for regulatory and developmental success. DHC combines specialized in-house CGT experience and the use of a proprietary toolkit when customizing an audit for your program.

QP support

Dark Horse eligible QPs are experts in global regulatory standards. Common eligible QP client requests include training and education on the roles of QP as well as QP audits and remediation. Please contact DHC for further discussion should you require batch certification or licensing support.

Interim functional leadership

For clients currently without internal leadership focused on this core capability, senior DHC experts can provide interim expertise and leadership with the goal of enabling the clients to identify, hire, and onboard internal candidates in a timely manner.

Other Core Capabilities

DHC Experts in

Quality Assurance

In need of a business consult?

We're here to help.
Request Consultation
Text Link
Facilities, Manufacturing, & Compliance
Text Link
Clinical Regulatory
Text Link
Diligence & Business Strategy
Text Link
Market Expertise
Text Link
Quantitative Modeling
Text Link
Project & Program Management
Text Link
Nonclinical Development
Text Link
Regulatory Affairs
Text Link
Facility Design & Engineering
Text Link
Quality Assurance
Text Link
Manufacturing Operations
Text Link
Device Development
Text Link
Analytical Development
Text Link
Product & Process Development