The regulatory, business and scientific landscape of drug development is changing constantly, no matter if you are virtual company, academician, or a traditional pharmaceutical company. Synergy Bioscience’s industry-veteran professionals use their collaborative approach and deep scientific and regulatory understanding of every molecule in development guides you to the best strategy for bringing a novel therapy to market and design custom studies and programs that reduce risk and accelerate timelines.
From early discovery to manufacturing support, our program managers, regulatory advisors and scientific experts are uniquely qualified to navigate your unique journey, every step of the way. We will also help you team up with entrepreneurs or investors to finance your development program.
• Our seasoned industry professionals have significant work experience within pharmaceutical and biotechnology companies, collectively participating in the development of17 approved products.
• We work closely with you to develop customized plans that increase efficiency and reduce risk to help you realize your product’s value.
• We can help with any level of development, from early phase to late stage, and provide expertise on compliance, documentation, validation and clinical trial development.
For more than 12 years, SYNERGY has been your partner in the development of important and life-changing therapeutics. Consulting across a wide range of therapeutic areas, our preclinical, clinical, manufacturing biostatistics and regulatory consultants have broad, interdisciplinary therapeutic knowledge and an in-depth understanding of global and local market landscapes and regulatory guidelines.
• Large pharmaceutical and biotechnology companies benefit from SYNERGY’s reservoir of experts to address gaps in strategic resourcing, enhance existing resources or engage in longer-term joint development partnerships.
• Virtual entities and small or emerging biotechnology, pharmaceutical and diagnostic/medical device companies benefit from our development expertise and experience with regulatory agencies.
• Our services span the development continuum from preclinical through post-approval and are customized to address specific development challenges of small molecules and biologics, vaccines, medical devices and companion diagnostics.
In addition to a breadth of product development expertise, SYNERGY consultants, scientists, engineers and other product development professionals provide specialized expertise to help clients successfully navigate challenges and realize opportunities in the following areas:
SYNERGY physicians, scientists, regulatory professionals and biostatisticians have firsthand knowledge of state-of-the-art clinical, regulatory and commercial program strategies, from first-in-human testing through registration, including post-approval studies and product optimization strategies. In addition, SYNERGYimmediately can access seasoned industry professionals and thought leaders through its affiliate network of independent consultants across numerous therapeutic and technical disciplines.
SYNERGY experts work with you to design a drug development plan that meets current regulatory standards and aligns with the most up-to-date perspectives of Regulatory Agencies. Your plan covers all CMC, nonclinical, and clinical requirements and includes detailed cost estimates and timelines. We can help your company formulate development strategies ranging from lead candidate selection to final regulatory submissions and post-market activities. Our global perspective and scientific expertise will ensure success by adding efficiency and manageability to your development program.
Our team can help you create product development strategies meeting international standards, focusing on regulatory and toxicology requirements. We help prepare the nonclinical studies required for next phase of Clinical Development, and manage Chemistry, Manufacturing and Controls (CMC) issues such as formulation changes, and review, management and filing of submissions worldwide in Common Technical Document (CTD/eCTD) format, including Pre-INDs, INDs, CTAs, BLA, NDAs, NDSs, MAAs, 510(k)s, PMAs, IMPDs, Pre-Submission Briefing documents, Investigator’s Brochures, Annual Reports, and Integrated Summaries.
To assemble a comprehensive drug development plan, the skilled scientists at SYNERGY can:
• Review existing and planned clinical studies to ensure your proposed strategy is in line with completed studies and similar development programs
• Provide brief study synopses detailing the design and rationale of each study
• Identify potential risks in the overall development plan as well as mitigation strategies
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