A Seraphim core service is helping clients identify, create, analyze and capitalize on existing and new opportunities.  Our unique approach to integrating deep knowledge and experience across scientific, IP, regulatory, manufacturing, marketing, reimbursement and commercial operations enables realization of exceptional opportunities.  Whether its product ideation, inbound or outbound licensing or partnering, we can help you shape and analyze the opportunity, find and assess the right target, negotiate the deal and manage the relationship to success.

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We provide comprehensive support to pharmaceutical companies throughout the entire drug development and  commercialization process. Our scope of experience includes new drugs, 505b2, simple and complex generics, and combination drug-devices and OTCs. Our experts have a wealth of experience in development, manufacturing, preclinical and clinical studies, regulatory submissions, commercial and market access strategies. Let us help you with initial and lifecycle management, distribution, federal, state and foreign regulation.

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Developing and executing innovative strategies to complex, often novel regulatory, quality and compliance challenges is a core Seraphim advisory role. Our team has been responsible for successful first time and “can’t be done” approvals and compliance remediations.  We dive deep into and integrate the full spectrum of technical, scientific, regulatory, legal, operational and commercial factors that make the differences between success, mediocrity and failure.  We can identify and solve hidden problems that most silo-driven consultants cannot see or understand, and help you build credible relationships with regulatory authorities. 

The Seraphim team understands the unique needs, issues and perspectives of attorneys and accountants.  Combining our hands-on technical, operational commercial experience with that understanding and discretion enables our legal and accounting clients work quickly and effectively.  From support on transactions and offerings, dispute resolution, expert witnessing, investigations and compliance mitigation, count on us to support you with the right advice, insight and action.

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We provide comprehensive support to pharmaceutical companies throughout the entire drug development and  commercialization process. Our scope of experience includes new drugs, 505b2, simple and complex generics, and combination drug-devices and OTCs. Our experts have a wealth of experience in development, manufacturing, preclinical and clinical studies, regulatory submissions, commercial and market access strategies. Let us help you with initial and lifecycle management, distribution, federal, state and foreign regulation.

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Our team has a deep understanding of the unique challenges and requirements for medical device, in vitro diagnostics, software/mobile and combination products.  Seraphim team can help you address regulatory and product development strategy, creation and execution of quality management systems, design control, and V&V activities, sourcing of materials, components and manufacturing, clinical, non-clinical and human factors testing, submissions and compliance issues.

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Our team has decades of experience developing, manufacturing, testing, approval, regulation and quality management of biologics, vaccines, gene and cellular therapies.  We help companies understand navigate complex regulatory requirements and streamline product development, manufacturing relationships to optimize time and risk to market. We assist with strategic planning, licensing, and partnering efforts to ensure the long-term success of our clients in this rapidly evolving field.

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Seraphim team members have deep outsourcing experience from both sides of the table in research, clinical, pre-clinical, manufacturing, distribution and commercial operations.  We can help you develop outsourcing strategies, locate, analyze, qualify, contract, manage and audit vendors and programs, improve relationship performance, prevent and resolve disputes.  Use the Seraphim’s team reach and experience build a successful outsourcing network.

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