Regulatory Expertise You Can Rely On
We provide clear, structured guidance to help organizations understand and meet regulatory expectations for advanced biologic products.
Quality & Compliance Support
Our consulting services reinforce GMP/GTP alignment, documentation accuracy, and overall process reliability across development stages.
Opening Hours
Monday – Friday 9.00 – 5.00 PM PST
Saturday – Sunday Closed
A Higher Standard of Biologics Consulting
At Advanced Cell And Tissue Solutions, we provide precise, objective consulting support for organizations developing cellular therapies, gene therapies, and tissue-based products. Our guidance is built on professionalism, regulatory alignment, and scientific integrity—ensuring your development process remains clear, compliant, and well-supported at every stage.
Regulatory Consulting Support
We help organizations understand regulatory expectations through clear guidance, structured planning, and accurate interpretation of current requirements.
Quality & Compliance Alignment
Our team supports the development of quality systems, documentation practices, and operational processes that reflect industry and regulatory standards.
Strategic Product Development
We provide direction across development stages, helping teams plan effectively, evaluate readiness, and make informed decisions to advance their products.
Specialized Tissue & Therapy Expertise
We offer focused insight into cellular, gene, and tissue-based product requirements, including compliance considerations and scientific support.
What We Offer
Our Services
Regulatory Consulting
Clear guidance on regulatory pathways, documentation requirements, and submission planning to support compliant product development.
Quality & Compliance Support
Assistance in building and maintaining quality systems that meet industry expectations, including documentation, processes, and audits.
Product Development Strategy
Structured support to help plan development stages, assess readiness, and guide products toward safe and responsible progression.
Tissue-Based Product Expertise
Specialized insight into requirements for human tissue and tissue-based products, including alignment with 21 CFR 1271.
Cellular & Gene Therapy Guidance
Consulting focused on the unique needs of advanced biologic modalities, covering CMC expectations and development considerations.
Additional Scientific Support
Support for evaluations, documentation reviews, and nonclinical planning to strengthen overall development readiness.
Regulatory Risk Assessment
Evaluation of potential regulatory challenges, gaps, and requirements to help teams anticipate issues and strengthen overall readiness.
Documentation & Submission Support
Guidance in preparing organized, accurate materials for regulatory interactions, ensuring clarity, consistency, and compliance.
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FAQs
Have some Questions?
We’re open Monday–Friday, 9 AM to 5 PM PST. You can also contact us online anytime, and we’ll follow up promptly.
Most consultations can be scheduled within a few business days, depending on availability and project requirements.
Yes. We support organizations at various stages of development and welcome inquiries from new clients seeking regulatory or scientific guidance.
We will review your product, development stage, and objectives to determine the type of support needed and outline the next steps clearly.
Yes. We provide both single-project consulting and long-term engagement options based on your needs.
Yes. Most consultations can be conducted virtually, allowing us to support teams regardless of location.
Partners
