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

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

 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

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

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)