Partner With Us Today
Our Mission:
Provide innovative solutions to the biotech industry for robust product development and comprehensive documentation to ensure quality, compliance and successful market readiness.
Our Vision:
Improving patient healthcare through better diagnostic solutions
Script Molecular is a biotech consulting firm in San Francisco, CA. We believe experience and knowledge drive success. Access to industry professionals with deep scientific and technical knowledge streamlines product development. When clients partner with us, they build effective strategies for successful product development and commercialization while saving time and money.
Our experts will work with you to identify applicable processes to ensure Quality and Regulatory compliance
Script Molecular consultants have been trained by the best in the industry on developing products under regulatory compliance for agencies including the FDA, WHO, MHRA, EMA and IVDR.
We are experts in developing strategies for all phases of product development from concept to market along with post-market surveillance and monitoring. Our consultants will work with your team to develop validation and verification study designs under Design Controls as defined under 21 CFR 820.30 of the Federal Register.
Regulatory Support
The Script Molecular team has successfully secured FDA clearances and approvals for over a dozen medical devices in the U.S., along with numerous global launches. Our regulatory experts specialize in developing robust regulatory strategies, managing Pre-Submissions and full Submissions, engaging directly with the FDA, and overseeing comprehensive post-launch surveillance and compliance monitoring.
New Product Development (NPD) Support
Outsource your product development, technical and process development, along with your documentation needs to us and execute your projects with agility and precision.
As every product and project is unique, our team of experts provide a tailored experience, working alongside you through assessment, strategy, planning, and implementation to meet your evolving needs. From product design and development to tracking, workflow consultations, and reviews, we ensure our work not only meets but exceeds your expectations.
We specialize in product development and documentation under strict quality and regulatory compliance. Script Molecular will help navigate the complexities of bringing your product to market by identifying and implementing the right processes to ensure full compliance.
Whether it’s a small-scale project or a large initiative, you can rely on us to develop your product and manage all required documentation with excellence and compliance at the forefront. Let’s bring your innovation to life—together.
Your Strategic Ally in New Product Development and Commercialization
At Script Molecular, our team of seasoned executives, product developers, scientists, technical writers, quality and regulatory experts brings decades of experience in commercializing IVD medical devices across the U.S. and global markets. We specialize in molecular diagnostic technologies, along with immunoassays, and tissue diagnostics.
With a strong foundation in ISO standards and FDA Design Controls, we drive products from concept to market by developing strategic plans, designing FDA-compliant analytical V&V studies and clinical protocols, formulating reagents and controls, and managing seamless transfer to manufacturing along with scale-up. Our expertise extends to QMS development / implementation and navigating pre-submissions and regulatory submissions both domestically and internationally.
Backed by deep industry knowledge, extensive resources, and a result-driven approach, we provide efficient, high-quality solutions that ensure compliance, accelerate time to market, and exceed expectations.
Tailored Expertise
At Script Molecular, we offer a tailored approach for each unique product. We work closely with you through assessment, planning, development and implementation to meet your company’s evolving needs. From tracking and workflow consultations to comprehensive reviews, we’re with you every step of the way ensuring a smooth launch for products that make a meaningful impact on patients' lives.
