Consulting and advisory services
Transforming visions into realities: Our consultancy and advisory services tailored to your success
Transforming visions into realities: Our consultancy and advisory services tailored to your success
Geistek Pharmaceuticals leverages its extensive expertise spanning three decades to provide comprehensive guidance to clients throughout the entire journey of drug development. With our seasoned asset development, regulatory consulting, and commercial consultants, we cater to a diverse range of global clients, including biotech startups, prominent pharmaceutical companies, and medical device developers. Moreover, we extend our support to research, investment, and legal firms operating in the life sciences industry, delivering tailored solutions to meet their unique requirements.
Expert consulting and advisory services for nonclinical and pre-clinical development, accelerating your drug and device programs to market. Our experienced team will collaborate with you to design and optimize a cost-effective nonclinical program, integrating it seamlessly with other development components. We offer comprehensive services, including lead optimization, study design, data interpretation, and regulatory support for submissions. With our expertise and integrated approach, we streamline your nonclinical development process and enhance your path to regulatory approval.
By leveraging our extensive knowledge and capabilities, we provide insights and solutions for various types of products, including small molecules, large molecules, biologics, and medical devices. Our nonclinical experts collaborate closely with our CMC, clinical, and regulatory teams to ensure a holistic approach and effective integration of your nonclinical program within the overall development strategy.
With Geistek Pharmaceuticals as your partner, you can benefit from our comprehensive range of nonclinical development services, including pharmacology, toxicology, ADME/PK, and regulatory support. Our dedicated team will assist you in developing nonclinical content for regulatory submissions, reviewing regulatory issues, and representing your interests in regulatory agency meetings. Trust Geistek Pharmaceuticals to guide and optimize your nonclinical and pre-clinical development, bringing your products closer to market success.
Comprehensive due diligence and asset valuation services to optimize your investments and maximize value. Our expert team provides thorough assessments and analysis to support informed decision-making in the pharmaceutical and biotech sectors. Whether you are considering mergers, acquisitions, licensing deals, or investments, our due diligence services offer valuable insights and risk evaluation.
With extensive industry knowledge and a meticulous approach, we conduct in-depth assessments of assets, including drugs, therapies, technologies, and intellectual property. Our team examines scientific data, regulatory status, market potential, competitive landscape, and financial considerations to provide a comprehensive evaluation of the asset’s value and potential risks.
Geistek Pharmaceuticals’ due diligence services go beyond standard assessments. We offer customized solutions tailored to your specific needs, ensuring a thorough analysis and identification of key value drivers and potential challenges. Our goal is to empower you with the information and insights necessary to make well-informed investment decisions and maximize the value of your assets.
Partner with Geistek Pharmaceuticals for reliable due diligence and asset valuation services that support your strategic investment decisions and drive success in the pharmaceutical and biotech industries.
Effective medical and value communications to convey the impact and value of your products. Our expert team specializes in developing comprehensive communication strategies that effectively communicate the medical and economic benefits of your pharmaceutical products to various stakeholders, including healthcare professionals, payers, and patients.
We understand the importance of clear and compelling messaging in today’s complex healthcare landscape. Our medical and value communications services encompass a wide range of activities, including developing scientific content, creating educational materials, conducting health economic assessments, and crafting persuasive value propositions.
Geistek Pharmaceuticals’ team of experienced medical writers, health economists, and communication specialists collaborate closely with you to understand your product’s unique value proposition and target audience. We employ evidence-based approaches and strategic messaging techniques to ensure your messages resonate with the intended recipients and drive informed decision-making.
With our medical and value communications services, you can effectively articulate the clinical benefits, economic value, and patient outcomes associated with your products. Whether you need assistance in developing publications, health technology assessments, or market access dossiers, we are here to support you in delivering impactful communications that make a difference.
Facilitating market access for your pharmaceutical products. Our market access experts are dedicated to helping you navigate the complex landscape of reimbursement, pricing, and market entry strategies to ensure the successful commercialization of your products.
We understand that gaining market access is a critical step in maximizing the reach and adoption of your pharmaceutical products. Our team works closely with you to develop tailored market access strategies that align with your product’s value proposition, therapeutic area, and target markets. We conduct comprehensive assessments of payer landscapes, reimbursement policies, and pricing dynamics to inform our strategic recommendations.
Geistek Pharmaceuticals’ market access services encompass a range of activities, including health economics and outcomes research (HEOR), value dossier development, pricing strategy development, and payer engagement. We leverage our expertise in health technology assessment (HTA) and market access negotiations to help you secure optimal reimbursement and pricing agreements.
By partnering with Geistek Pharmaceuticals, you can access our deep understanding of global healthcare systems, payer requirements, and market dynamics. We collaborate with you to develop evidence-based value propositions, demonstrate the economic value of your products, and communicate their clinical benefits to key stakeholders.
Advancing medical device and diagnostics research for improved patient outcomes. Our dedicated team of experts specializes in conducting comprehensive research and providing strategic insights to support the development and commercialization of medical devices and diagnostics.
We recognize the unique challenges and regulatory requirements associated with medical device and diagnostics research. Our research services encompass all stages of the product lifecycle, from early feasibility assessments to post-market surveillance studies. We employ a multidisciplinary approach, combining clinical, scientific, and regulatory expertise to deliver robust and reliable research outcomes.
At Geistek Pharmaceuticals, we collaborate closely with clients to design and execute tailored research studies that address specific objectives and regulatory guidelines. Our services include clinical trial design, data collection and analysis, health economic evaluations, and outcomes research. We strive to generate meaningful evidence to demonstrate the safety, efficacy, and cost-effectiveness of medical devices and diagnostics.
By partnering with Geistek Pharmaceuticals, you gain access to our extensive network of key opinion leaders, healthcare professionals, and research sites. We work diligently to ensure adherence to regulatory standards and facilitate the smooth execution of research studies. Our goal is to support the development of innovative medical devices and diagnostics that make a positive impact on patient care.
Navigating complex regulatory landscapes for successful product approvals. Our Regulatory Affairs team is dedicated to helping clients navigate the intricate and ever-changing regulatory requirements to ensure timely and successful product approvals.
With deep expertise and knowledge in global regulatory frameworks, we provide comprehensive regulatory strategies and support throughout the product development lifecycle. From early-stage development to post-market compliance, our team collaborates closely with clients to develop customized regulatory pathways tailored to their specific needs and target markets.
Geistek Pharmaceuticals understands the critical importance of regulatory compliance and the impact it has on product success. Our services encompass regulatory submissions, dossier preparation, labeling and packaging compliance, pharmacovigilance, and post-market surveillance. We work diligently to anticipate and address potential regulatory hurdles, minimizing delays and optimizing the path to market.
By partnering with Geistek Pharmaceuticals, you gain access to a team of experienced regulatory professionals who have extensive knowledge of regional and international regulations. We stay abreast of regulatory updates and industry trends, ensuring that your products meet all necessary requirements for market entry.
We are setting new standards in clinical excellence. By prioritizing meaningful metrics, we are consistently delivering economic value to our clients. Our extensive experience encompasses both small-scale studies and large, intricate multinational projects.
At Geistek Pharmaceuticals, our team of development experts leverages their expertise to ensure accessibility of products and treatments to patients through our Site & Patient Solutions. This encompasses various aspects, including utilizing patient insights for optimized trial design, engaging with patient advocacy groups, and implementing customized patient recruitment strategies.
INTRODUCTION ¹. CARVYKTI™ (ciltacabtagene autoleucel – Johnson & Johnson) was approved by the U.S. Food and Drug Administration (FDA) in February 2022 for the treatment