Analytical Development

Method development

Our experts assist in identifying and selecting appropriate analytical methods for your product and in developing and optimizing such methods to be fit-for-purpose.

Specification setting

We help you identify product critical quality attributes (CQAs) and assays best suited for release or product characterization. We use statistical process analysis tools, combined with a wealth of experience regarding global regulatory expectations, to help you select appropriate specifications for your individual product and phase of development.

Qualification and validation

We design protocols for performance verification of your analytical method, oversee method qualification/validation studies, and write or review technical reports summarizing study results.


Method transfer

We hand carry your analytical method to its new home to ensure success of your method transfer. We prepare your documentation, oversee planning and execution of the method transfer, and provide in-person oversight for the transfer at your CRO/CMO.

Comparability testing

We design a customized strategy to enable establishment of comparability to ensure that manufacturing changes (be they in location or process or both) are satisfactorily comparable, streamlining your future regulatory needs. We have extensive experience in study execution, data analysis, report writing, and drafting and submitting regulatory filings; we are also available to represent you at regulatory meetings to discuss those filings.

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.

Next-generation sequencing (NGS)

We provide both technical and strategic support for NGS-related projects, whether you need to determine goals and optimal service providers for your sequencing studies, design experiments, analyze data outputs, or consider the impact to your therapeutic program. Common requests include analyzing packaged AAV sequences: involving data analysis, experimental design, interpretation of results, and risk assessments.

Off-target analysis

We offer wide ranging strategic and tactical support for off-target genome editing analysis, including providing clients with advice on the overall off-target strategy, experimental design, and identification of service providers. DHC can also help clients understand the impact of their off-target data, including providin support for risk assessments, mitigation strategies, and responses to regulatory information requests.

Other Core Capabilities

DHC Experts in

Analytical Development

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