Drug Device Combo Products

The demand for sophisticated drug-delivery devices continues to drive novel product development and innovation. The use of combination products appears to be on the verge of unprecedented growth in the healthcare sector and attracting the attention of an increasing number of medical device manufacturers, pharmaceutical companies, and durable medical equipment and supply companies. At Pace Analytical, we understand that while this convergence of drugs/biologics and devices brings many exciting, new opportunities and business ventures for the manufacturers of these products, it also brings a host of new challenges and regulations. Pace Analytical Life Sciences has the experience and expertise to embrace these opportunities and manage these challenges. We have extensive experience in the clinical, regulatory, quality and statistical testing aspects of drug, biologic, diagnostic and medical device development. We stay abreast of the current trends in the industry―as well as the current regulatory and business environments that affect biotech medical device, equipment and pharmaceutical companies.

We are uniquely positioned to support the analytical testing needs of clients who are developing combination products. With our in-depth technical knowledge, state-of-the-art lab facilities and vast array of analytical services that support the pharmaceutical and medical device industries, Pace Analytical Life Sciences can provide its combination product clients with the analytical guidance and reliable scientific data that can withstand the scrutiny of a regulatory approval or audit.

At every stage of the product development process, we will be there to provide strategic insight and expert implementation. You can be assured that when you work with Pace Analytical Life Sciences, you are working with a highly experienced, knowledgeable staff that will be there with you every step of the way. 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 and compliant.

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

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

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.

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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.