Your Roadmap To Revolutionary Therapeutic Solutions

About
our company

At AstroBio Solutions, we are focused on supporting and helping pharma & biotech companies face their most complex quality and clinical challenges head-on. With deep industry expertise and an overwhelming commitment to regulatory and clinical excellence, we work with organizations of various sizes to build/optimize quality and clinical systems, ensure compliance, and accelerate clinical development. We strive to empower our clients with expert guidance, practical solutions, and support that can help drive success from bench to commercialization and beyond.

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Our Services

Quality Control & Quality Management

Support for clients in the development and optimization of GMP complaint Quality Control and Quality Management systems, including method validation, deviation management, CAPA processes, data integrity, and audit readiness.

Clinical & Regulatory Support

We provide strategic clinical and regulatory support, including CTA and IND preparation, submissions to regulatory agencies, GCP, protocol, financial, and ethical standard adherence and compliance, inspection preparation and readiness, and full operational clinical trial life cycle management from startup to closeout.

Analytical Development Support

Discover our analytical development support for biologics and cell therapy products, including method development, optimization, and qualification for identity, purity, potency, and stability, ensuring phase appropriate strategies, method transfer, and regulatory compliance from pre-clinical development to commercialization.

Other Services

Document Drafting & Review

Document drafting and review can often be a daunting task early on within quality and clinical departments. Our specialized team can assist with various documents from recommendation, drafting, review, and implementation.

Data Entry & Analysis

Clinical and qualification data can pile quickly; especially with large trial enrollment or development replicates. We can assist with expert analysis and data entry to streamline report writing and business decisions.

Future Services

  • New companies often struggle with what is needed to design and implement a GMP manufacturing or testing area. We plan to be able to assist with design specifications that are necessary to have a regulatory compliant area based on your market area.

  • Hiring new staff or just wanting to do formal and documented training? Our team will be able to deliver quality training to strengthen any GxP skillset and leave your company confident in employee understanding and capabilities.

  • Assay development is an important part of any GMP laboratory. Our team of scientists will be capable of troubleshooting or provide advice on development blocks. We will also be capable of coming onsite to train your team or troubleshoot with you equipment.

  • Looking into vendors for materials, reagents, or outsource testing can be difficult. With various options available it can be overwhelming to decide who is best suited for your needs. Our experts can provide guidance on vendor audit and qualification to ensure confidence in company decisions without compromising quality.

  • Are you seeking to onboard staff or partner with a new clinical site? Our team can equip you with the tools needed to appropriately mentor, support, and oversee your staff’s training that is crucial for ensuring patient safety, regulatory compliance, employee satisfaction and retention, and the overall success of a research program.

Contact Us

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