Chimera Consulting North America LLC is a consulting firm specializing in drug, biologic and medical device technical development, quality assurance and regulatory affairs, in particular for combination products. Chimera assists clients in establishing technical development and regulatory strategies, drafting and reviewing submission quality documents and providing regulatory agency liaison and support to companies engaged in the development, manufacture and marketing of drugs, biologics, medical devices and in particular, combination products. Chimera assists large and small clients in navigating complex regulatory and product development frameworks, especially those that result when different medical product types are combined.
Chimera works with clients in various ways, supporting the pre-clinical, clinical, development, manufacturing, quality, regulatory affairs and project management functions. Ongoing relationships with clients are preferred but sometimes only an answer to a question or an opinion is needed, or an approach needs confirmation. Relationships often begin with an initial consultation on a particular problem or assignment. Sometimes they begin with an in-house training. The objective may be accomplished in an initial consultation or an initial assignment may lead to an ongoing relationship involving periodic contacts and a broader long-term involvement in product development, registration, marketing or compliance.
The development, registration and post-marketing compliance of drugs, biologics and medical devices depends on effectively executing technically complex and highly regulated industrial processes. Combining two or more medical product types further complicates the process, producing a fourth medical product type, a combination product. Combination products are formed by combining two or more medical product types through either integration, co-packaging or cross-labeling. There are 18 different ways that two medical product types can be combined so, a one-size-fits all approach to the development and regulation of combination products is not feasible. FDA can apply any regulation and involve any organizational component it deems necessary to assure that a particular combination product is safe and effective. The regulatory requirements that FDA normally applies to individual constituent parts of a combination product (i.e., drug, biologic, medical device) are different. Applying these laws, regulations, guidance concurrently produces uncertainty about how to comply with multiple regulatory requirements.
The Primary Mode of Action of a particular combination product determines which FDA Center has primary jurisdiction for its regulation. Even after a Center with primary jurisdiction is identified, it still may not be clear, at a detail level, how the Center will apply disparate regulatory requirements to the combination product. Center reviewers tend to apply regulations that they are familiar with but secondary requirements may also come into play. Consultative or collaborative review of combination products involving multiple FDA Centers is not uncommon.
To efficiently develop, manufacture and market medical products, companies need regulatory process predictability. Since the establishment of FDA’s Office of Combination Products progress has been made in clarifying how FDA regulates combination products. This has been accomplished through the promulgation of regulations, guidance documents and the posting concept papers on OCP’s website . But many regulatory ambiguities remain. FDA calls these post-marketing issues. Chimera refers to these as downstream issues since some arise prior to marketing.
An industry survey conducted in 2009 by the Regulatory Affairs Professionals Society and the Combination Products Coalition revealed that developers, manufacturers and marketers of combination products want more regulations and guidance on how to manage combination product downstream issues. Absent this, developers, manufacturers and marketers of combination products are moving forward carefully, seeking input from regulators and experts with experience in the intricacies of combination product development, registration, marketing and compliance.