Somasthetics.
Therapeutic
Excellence.
A developer of therapeutic products using advanced tissue technology. From contracted quality control to contract manufacturing of donated human tissue-derived products — honoring the gift of donation and providing the highest quality products to those in need.
Who we are.
Somasthetics has been in the pharmaceutical and tissue banking arena, with a combined experience of over 45 years, providing a strong background and understanding in both operations and regulations.
Somasthetics is a developer of therapeutic products using advanced tissue technology, and pride itself by providing the highest quality of products, to fulfilling the family's wishes, by honoring the gift of donation, to providing the safest manufactured products to those in need, by enhancing the lives of others.
45 Years of Expertise
Somasthetics has been in the pharmaceutical and tissue banking arena with a combined experience of over 45 years, providing a strong background and understanding in both operations and regulations.
Honoring the Gift of Donation
Providing the highest quality of products, fulfilling the family's wishes, honoring the gift of donation, and providing the safest manufactured products to those in need.
Advanced Tissue Technology
A developer of therapeutic products using advanced tissue technology — enhancing the lives of others through precision manufacturing and rigorous quality systems.
45+
Years Combined Experience
99.8%
Quality Standard Adherence
4
Regulatory Frameworks
cGMP
FDA Compliant Manufacturing
Service Modules
Three core divisions covering the full quality and manufacturing lifecycle — from contracted quality control to tissue-derived product services.
01
Contracted Quality Control
Comprehensive quality control services ensuring your products meet the highest regulatory and safety standards.
- ·Inspection Management
- ·Documentation
- ·Material Verification
- ·Testing and Certification
02
Contract Manufacturing Services
End-to-end contract manufacturing with rigorous compliance and production management for pharmaceutical and tissue-derived products.
- ·Quality Control
- ·Production Management
- ·Compliance
- ·Testing and Inspection
- ·Customization
03
Donated Human Tissue-Derived Products
Full lifecycle management of donated human tissue-derived products with strict regulatory oversight and quality systems.
- ·Donor Screening
- ·Medical Chart Review
- ·Donor Eligibility Determination
- ·Release to be Further Manufactured
- ·Management of Quality System
- ·Oversight of Manufacturing Activities
- ·Investigation of Complaints
- ·Supplier Audits
- ·Validation
Regulations and Standards
Regulations and standards that Somasthetics adheres by.
GMP
GMP — Good Manufacturing Practice
A set of requirements used in various industries, including pharmaceutical manufacturing, to ensure products meet their quality standards. GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff.
CFR §211
FDA CFR Title 21 Part 211
Sets the cGMP regulations for finished pharmaceuticals. It establishes the minimum requirements for the manufacturing, processing, packing, or holding of products that are classified as drugs.
CFR §1271
FDA CFR Title 21 Part 1271
Regulates human cells, tissues, and cellular and tissue-based products (HCT/Ps). Somasthetics follows Subpart C — Donor Eligibility and Subpart D — Current Good Tissue Practice.
USP <797>
USP Chapter <797>
Established by the United States Pharmacopeia Convention ('USP'), a scientific nonprofit organization dedicated to ensuring the quality of the American drug supply, USP <797> outlines the necessary procedures for compounding sterile drug preparations.
Start your inquiry.
Tell us about your quality, manufacturing, or tissue-derived product needs. We'll respond within one business day with a tailored assessment — no obligation.
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