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Here you will find answers to the most important questions about our services.
We provide engineering, project management, due diligence assessments, technology transfer support, and expertise in aseptic formulation and fill-finish processes. In addition, we coach biotech start-ups to strengthen their in-house capabilities for clinical and commercial manufacturing.
Our team ensures seamless transfer of processes and knowledge by aligning technical, regulatory, and operational requirements. We help adapt process designs and use common project management principles for great project transparency for all stakeholders.
Aseptic formulation and fill-finish are critical steps where sterile drug products are prepared and filled into vials, syringes, or devices. We design and optimize robust processes that meet global GMP and regulatory standards, reducing contamination risks and ensuring patient safety.
Yes. We evaluate processes, facilities, and technologies to identify risks, validate scalability, and assess compliance before strategic decisions or investments are made.
We offer hands-on coaching, training, and technical guidance to accelerate scale-up and regulatory readiness. Our goal is to help emerging companies navigate the complexities of manufacturing and avoid costly delays.
We can add value at any stage—from early-stage clinical development to large-scale commercial production. Early involvement helps identify risks and streamline technology transfer for long-term success.
Through structured project management, state of the art process design, and regulatory alignment, we help clients move confidently from pilot batches to commercial supply, ensuring timelines and quality standards are met.
We combine technical expertise with pragmatic project leadership. By aligning stakeholders, tracking milestones, and proactively managing risks, we ensure complex projects are delivered efficiently and on time.
We act as a bridge between clients and manufacturing partners, ensuring clear communication, technical alignment, and smooth collaboration across all parties.
Yes. We support projects both on-site at client facilities and remotely, depending on project needs and location.
We support both innovative biotech start-ups and established global pharmaceutical companies. Each partnership is tailored to the scale and needs of the client.
Yes. Our expertise spans across small start-ups bringing their first molecule to clinic and large organizations advancing commercial therapies worldwide.
We work across biologics and pharmaceuticals, with strong experience in injectable therapies and vaccines requiring aseptic formulation and fill-finish manufacturing.
Our team integrates regulatory expectations into every step of process design, technology transfer, and manufacturing scale-up. We align with FDA, EMA, and ICH guidelines to ensure compliance from development to commercialization.
We bring years of hands-on experience in GMP facilities, from R&D through large-scale manufacturing. Our team has successfully led aseptic operations, equipment qualifications, and regulatory audits.
We combine deep technical expertise with a pragmatic, solution-oriented approach. Clients value our ability to reduce complexity, accelerate timelines, and act as a true partner throughout development and manufacturing.
You will work directly with our experienced team of engineers, project managers, and consultants, including our founder Steven Altorfer and senior experts with backgrounds in biotech and pharmaceutical operations.
Our leadership has extensive experience in engineering, aseptic processes, technology transfer, and regulatory compliance, gained through roles in global pharma companies and high-impact biotech projects.
Simply reach out via our contact form or email. We’ll discuss your program goals, assess your needs, and propose the best path forward.
We are headquartered in Switzerland and work with clients across Europe and globally. Our team supports both local and international projects.
Project timelines vary depending on scope and complexity. We support short-term assessments as well as long-term partnerships from early development through commercial launch.