CONSULTING SERVICES
In the highly competitive biopharmaceutical marketplace, the need to diversify, innovate, and globalize is greater than ever. Drawing on our unique fusion of scientific, regulatory, and business expertise, Biotec Partners provides flexible, strategic solutions designed to fit your specific products, stage of development, and company size and goals. Our services help biopharmaceutical and medical device companies shorten time to market, manage risk, access new global markets to maximize portfolio value, and maintain regulatory compliance.
Global product development
In today's marketplace, biopharmaceutical and medical device companies must leverage the global environment to develop products efficiently and gain market advantage, as well as return on investment. While opportunities abound, it is a complex playing field with many challenges.
Thriving in global markets
Having sound global product and portfolio strategies and leveraging specialized expertise and local resources around the world are essential for success. Companies need to prioritize their portfolios, including how and where to focus which products and which regulatory and clinical paths to take. Enhanced speed of patient recruitment and the potential for lower cost of clinical trials are just some of the benefits your company will reap from global product development.
Biotec Partners provides its clients with data and insight to help shape your global strategies for pharmaceuticals, biologics, medical devices, and combination products. We then provide expert resources to help propel your products over early stage hurdles, past key milestones, through first-cycle regulatory approvals and ultimately to achieve market access.
As a global leader in product development services, Biotec Partners can help speed time to market and promote long-term product / portfolio viability. Our goal is to help you to advance the commercial success of your products, and to optimize the benefit they provide to patients in need.
Key Offerings:
- Market Intelligence
- Comprehensive Product Development Strategy
- Product Global Expansion Strategy
- Health Authority/Agency Consulting, Advisory, and Liaison Services
- Clinical Trial Applications
- Comprehensive Labeling Services
- Clinical and Nonclinical Development Consulting
- New Product Acquisition Support
- Post Approval Lifecycle Management
Product globalization is also beneficial for managing the risk of product failure, avoiding approval delays due to non-compliance, and for achieving effective regulatory partnering (outsourcing) to drive efficiencies and pipeline productivity. Companies that partner with Biotec Partners can take advantage of brand extension to new markets, and benefit from informed decision-making through effective due diligence of acquisitions, partners, and suppliers. |
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Strategic Compliance
Our trusted experts, including renowned former regulators, know how to institute proactive compliance and have a strong track record of helping companies get out of regulatory crises. They are well versed in biopharmaceutical, medical device / diagnostic regulations, and are focused on the success of your products and company.
Biotec Partners has biopharmaceutical and medical device product compliance solutions for small and large companies alike, from global audits to loaned executives, ad-hoc advice or inspection readiness training. We help companies manage risk effectively in global markets to protect and grow product and company reputation and value.
Commercialization strategy services
It has become apparent that regulatory success does not automatically equate to commercial success. To succeed, companies must develop products with a commercialization strategy in place as early in development as possible. This way companies are more likely to achieve competitive advantage and a well defined value proposition for their products.
Developing with reimbursement and market access (RMA) in mind has become the new "make or break" of product commercial success. By understanding market access implications during development companies can design the right trial, create an optimal label, better leverage evidence-based or outcome-based medicine, and eliminate access hurdles by demonstrating patient, payer and provider value. Companies can also align clinical investment to payer reimbursement and patient access trends. |
