MULTI-PRODUCT
PRODUCTION SITE

Leading, full-service CDMO specializing in
collagen-based drug delivery technologies
and the development of additional novel
biomaterial products.

SYNTACOLL OVERVIEW

TRANSFORMING
CDMO
PARTNERSHIPS

End-to-end solutions from product design to manufacturing

INVENTING
NOVEL
TREATMENTS

R&D for new collagen formulations and API incorporation

ENSURING
COMMERCIAL-SCALE
MANUFACTURING

Capabilities and capacities for all production needs

INTEGRATING
QUALITY &
COMPLIANCE

Committed to achieving high quality and safety excellence

To learn more about Syntacoll, visit their website

VISIT SYNTACOLL

PRODUCTION CAPABILITIES

  • ISO 13485 Certified
  • GMP Certified and Holder of Multiple Regulatory Approvals
  • Clean room environment with GMP classes A-D (class 100 to 100,000), ISO 5-8
  • Production capability including:
    • Collagen rendering
    • Matrix production
    • Packaging and labeling
    • Serialization with aggregation
    • Testing
    • QP and QA disposition

RESEARCH & DEVELOPMENT

  • Development of novel collagen formulations
  • Incorporating new APIs into different formulations
  • Formulation and method development
  • Technology transfer into production and laboratory

QUALITY SYSTEMS & ASSURANCE

  • Quality system covers medical devices, medicinal products, and combination products
  • Inspected routinely by various authorities throughout the world
  • Qualified person on site with ability to certify product to market
  • Development of validation plans and execution
  • Quality assurance including:
  • Quality management system
  • Quality events
  • Change controls
  • Effectiveness checks
  • Documentation
  • Audit Program
  • Complaint Processing
  • Line clearance
  • Batch record review
  • Regulatory
  • Safety
  • Training
  • Recall Management
  • Deviation Management