Combination Product Testing Services

Pace Analytical Life Sciences is uniquely positioned to support the analytical testing needs of those clients who are developing combination products. With its in-depth technical knowledge and vast array of analytical services that support the pharmaceutical industry as well as the medical device industry, Pace Analytical Life Sciences can provide its combination product clients with analytical guidance and data that can withstand the scrutiny of a regulatory audit.

Combination products are defined in 21 CFR 3.2(e). The term combination product includes:

1. A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;

3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or

4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.

Pace Analytical Life Sciences offers the following services to support the development of combination products:

Analytical method development and validation for drug content/assay
Analytical method development and validation for impurity/related substance identification and quantitation
Analytical method development and validation to determine drug elution profiles
Elution Studies
Kinetic Drug Release Testing
Drug Coated Device Testing
Drug Device Testing
Inhalation Testing
MDI Testing
Anderson Cascade Impaction
ACT Inhalation
Drug Coated Stent Assay
Medicated Device Testing
Residual Solvent testing
Microbiology support
Physical testing of devices
Stability testing and storage per ICH conditions
Protocol Writing Services

Pace Analytical Life Sciences brings years of experience supporting the pharmaceutical and medical device industries with their analytical testing needs. We bring the highest level of quality and attention to detail to our clients to assure that their protocols and analytical testing programs are successfully executed..

We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited.

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Pace Analytical Life Sciences can provide its combination product clients with analytical guidance and data that can withstand the scrutiny of a regulatory audit.