Quality Systems & Compliance
Creation and refinement of quality management systems aligned with global standards
Internal and external quality audit preparation
CAPA and deviation management programs
Support during regulatory inspections and third‑party audits
Workforce training and competency monitoring
Supplier and vendor qualification programs
cGMP Manufacturing & Technical Support
Technology transfer planning, risk mitigation, and operational readiness
QTPP, CQAs, and CPPs for advanced therapy products
Process development, scale‑up/scale‑out, automation, and closed‑system workflows
Cell sourcing, banking, traceability, and GTP‑aligned practices
Qualification and oversight of raw materials and suppliers
Analytical method development, qualification, and validation
Comparability assessments and lifecycle process control
Cold‑chain strategy, logistics, and shipment coordination
Support in selecting and managing contract manufacturing and testing partners
Advanced Therapies & GMP Facility Support
Knowledge across cell, gene, and exosome therapy platforms
Conceptual design for cGMP cell culture and processing facilities
Support for cGMP compliance across manufacturing operations
Development of robust process control frameworks
Assistance with sourcing specialized and high‑risk raw materials
Product Development, CMC & Quality
Guiding programs through product development, CMC strategy, and quality oversight
Early‑stage feasibility evaluations with clear regulatory pathways
Market landscape and competitive analysis
Mapping regulatory and commercialization routes
Evaluation of readiness for commercial‑scale manufacturing
Regulatory Support
Guidance for HCT/Ps (361) and advanced biologics (351)
Navigation of accreditation and standards (FACT, JACIE, AABB, AATB)
Implementation of cGTP and cGMP compliance frameworks
Regulatory gap assessments and audit preparation
Development and Submission of Drug Master Files (DMFs) and Master Files (MFs)