Services.
Four pillars to boost your success in China and the United States.
Strategic
Advisory
We provide comprehensive consulting services tailored to your business lifecycle - from market entry to long-term growth acceleration. Our strategic advisory support covers:
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Market Entry & Expansion Strategy:
Develop customized market-entry roadmaps, assess regulatory readiness, and prioritize target geographies based on market size, competitive landscape, and policy environment. -
Growth Optimization:
Leverage innovative go-to-market (GTM) approaches to drive revenue, improve profitability, and align with regional market dynamics (e.g., China's evolving VBP, or the U.S.'s IDN-driven purchasing).-
Design segment-specific sales models
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Refine pricing strategy and reimbursement readiness
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Optimize resource allocation by market and product
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Portfolio Rationalization & Prioritization:
Streamline your product portfolio to focus on high-growth, high-potential segments - balancing innovation, regulatory complexity, and market demand.-
Identify which products to localize, scale, or sunset
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Conduct margin and volume trade-off analysis
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Reallocate investments to strategically important platforms
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Asset Restructuring & Partnership Strategy:
Evaluate underperforming assets and explore strategic alternatives such as local licensing, divestiture, or joint ventures to unlock value and de-risk the business.-
Execute carve-outs and spin-offs
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Build partner models aligned with growth and compliance priorities
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Support negotiation and deal structuring
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Local Team Capability & Operating Model Alignment:
Strengthen the commercial effectiveness and execution capabilities of your in-market teams through:-
Org structure design
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Talent assessment and development
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Performance model optimization (KPI alignment, incentive planning)​
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At Bretton, we don’t just deliver strategy decks - we work alongside you to define, operationalize, and accelerate the initiatives that will truly move the needle in complex and competitive markets.
China NMPA/
U.S. FDA Consulting
Navigating the regulatory landscapes of China and the U.S. requires deep expertise and strategic foresight. Our team offers comprehensive consulting services to streamline your path to market:​
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Regulatory Strategy Development: Craft tailored regulatory roadmaps aligning with your product's unique attributes and target markets.​
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Regulatory Pathway Analysis: Assess and determine the most efficient approval routes, whether through NMPA classifications or FDA 510(k), PMA, or De Novo pathways.​
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Pre-Submission Support: Prepare and facilitate pre-submission meetings with regulatory bodies to clarify requirements and expectations.​
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Clinical Evaluation and Trial Design: Design and manage clinical studies that meet regulatory standards, including leveraging real-world evidence where applicable.​
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Quality Management System (QMS) Implementation: Establish and optimize QMS frameworks to ensure compliance with regulatory requirements.​
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Post-Market Surveillance Planning: Develop strategies for ongoing compliance, including post-market clinical follow-up and vigilance reporting.​
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Our seasoned consultants, with decades of experience interacting with the FDA and NMPA, are dedicated to guiding you through the complexities of regulatory approval, ensuring a smooth and efficient journey to market.​
Operational enablement
We support clients in establishing legal entities in respective markets, building and developing high-performing local teams. Our services include:
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Legal Entity Formation: Navigating the legal requirements to establish your business presence.
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Staffing Solutions: Recruiting and developing local talent to drive your operations.
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Partnership Development: Leveraging our deep relationships with strategic partners, including local companies, distributors, and key state-owned enterprises (SOEs) in China, to unlock access, build influence, and create competitive advantages in the market.​
Commercialization
We partner with clients to design and execute end-to-end commercial strategies that accelerate revenue and establish a strong, credible presence in new markets. From marketing and sales to channel partnerships and service infrastructure, we help you build what it takes to win commercially.
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Our commercialization services include:​
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Marketing Strategy & Execution:
Develop targeted campaigns that align with customer segments, regulatory constraints, and market maturity - backed by KOL support and clinical validation. -
Sales Channel Development:
Identify, structure, and manage effective sales channels - whether direct, indirect, or hybrid - tailored to your product type and market access strategy. -
Service Model Design:
Build or refine your field support, technical service, and customer success models to ensure performance, retention, and post-sales satisfaction. -
Distribution partners & Commercial Enablement:
We connect you with high-impact local commercial partners - and help you activate those partnerships with clear onboarding, incentive alignment, and joint growth planning. -
Brand Strategy Design & Implementation:
We help you define your brand positioning, messaging, and visual identity to resonate with local stakeholders. We build the credibility international medtech companies need to establish trust and drive adoption in new markets.
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At Bretton, we don't just tell you how to go to market - we go to market with you, acting as your on-the-ground partner to ensure every plan is executed with precision and local relevance.