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In addition to our core business offering of global marketing and distribution, Silicon Beach Enterprise's Medical Marketing Group provides clients with numerous ancillary services, as necessary. Some of these services are performed in-house, and others are out-sourced to vendor-associates, specialists with whom we have worked for many years. Our network of vendor-associates are considered to be among the top experts in their field and this cooperative partnerships allows SBE to respond rapidly to our clients' diverse needs.
Product Design and Testing
Product design and testing is at the heart of successful new product development. It is at this stage that key product features can be identified and refined, so that SBE can ultimately introduce and position your product for maximum effect. Our vendor-associate in product design and testing has extensive experience in the esoteric art of technical characterization and evaluation.
Project Management and Vendor Liaison
As development projects grow, so too do the complexity and associated overhead. Experienced, systematic management is essential to keep a project for getting bogged down or off track. SBE can help you balance the need for administrative controls with the inevitable rush to get to market.
Regulatory Affairs Consulting
SBE has worked closely with our consultants in this area to provide clients with a sound regulatory affairs strategy. We conduct the submissions for you and all of the FDA contact and follow-up required to ensure that your product is approved in a timely manner. We can also initiate the EC approval/compliance process, and any individual non-harmonized country-by-country approvals needed to ensure your product can be sold in the widest possible range of markets. Approval types include FDA PMA, 510(k), CE mark, and country-by-country regulatory compliance.
Contract Manufacturing, Assembly, and Packaging
SBE can assist your company in taking its product off the drawing board and into finished, packaged form. Our associate-vendor for packaging provides a complete range of services including pharmaceutical "final fill and finish," liquid filling, device assembly and final packaging, clean room facilities, and warehousing. Regulatory compliance is maintained throughout the packaging or assembly process through strict adherence to internationally recognized good manufacturing practices. |
