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Emerging Start-ups

Small entrepreneurial firms drive innovations, but often struggle with limited funding and inadequate resources. A recent McKinsey industry report identifies regulatory requirements and the cost of clinical research as two of the most significant factors affecting a company’s ability to develop new drugs and technologies.

These challenges can be especially daunting for start-ups focused on breakthrough technologies that will establish new markets based on novel clinical indications and new patient groups.

Whether you are seeking to launch your product into the Asian, U.S., European or other international markets, Synergia Bio Sciences is a vital partner to help you throughout your product development process.Our experts will help you to identify, understand, and overcome regulatory and clinical development obstacles, avoid costly design and development delays, and speed your journey from product concept to commercialization.

Established Firms

Large, established biopharma companies, who are responsible for over 30% of all biopharma industry revenues, must continually adapt to technological advancements while maintaining product integrity and reliability.

Established companies are focused on launching next-generation technologies to improve patient outcomes, reduce costs and build entirely new markets through acquisition and development of breakthrough technologies.

Whether you are seeking to broaden your existing product claims and indications or need expert strategic regulatory and clinical trial guidance to enter new markets in the United States and internationally, Synergia Bio Sciences can help you to stay ahead of the competitive curve, balance risk, and achieve your specific business objectives.

Non India Based Firms

One of the most important aspects of getting a product to market in India is to know where to begin. For non India biopharma companies, especially those with novel and innovative applications, the regulatory pathway can often seem complex and difficult to navigate.

With Synergia Bio Sciences as your partner, you will gain a deep understanding of Indian regulations, often beyond what is available in published guidance documents. Synergia Bio Sciences is well-respected by the CDSCO. Our consultants and project managers have excellent rapport with agency leaders and reviewers, earned through years of working together on a broad range of regulatory submissions and client negotiations.

Synergia Bio Sciences will guide you through all of the phases of Indian market approval and clearance, design and manage your clinical trial
activities, and ensure that you comply with quality systems regulations for your product.

India Based Firms

Many India based firms seek to expand their markets to become strong competitors globally. Some international regulatory barriers, however, especially those in developing economies, can be difficult to surmount. Biopharma firms often devote tremendous amounts of time and money to determine requirements, conduct additional overseas clinical trials, and pay user fees.

While it is not possible to see products, "approved once and accepted everywhere," Synergia Bio Sciences can help firms to develop regulatory and clinical trial strategies that will most efficiently address requirements from a global perspective.

In addition to assisting clients with regulatory, clinical trial, and quality assurance challenges, Synergia Bio Sciences can guide clients through the complexities of obtaining the CE mark and serves as EU Authorized Representative for clients entering the European market.

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