INDs, NDAs, ANDAs, BLAs, eCTDs & global submission strategies
FDA 505(b)(2), biosimilar & advanced pathway expertise
Pre-IND, Type B/C Meeting prep & agency interactions
Regulatory writing, data integrity audits & submission review
FDA 483, Warning Letter & Consent Decree remediation
Change control, investigations & complaint handling systems
Clinical trial compliance, biostatistics & post-market surveillance
Third-party audits for FDA, EMA & WHO compliance
Integrated CMC & Tech Ops solutions
Expertise across vaccines, mAbs, cell & gene therapies
Flexible platforms: E. coli, yeast, CHO, HEK293, SF9, egg-based systems
Scale-up solutions: single-use 2000L to fixed 60K L capacity
Contamination control & workforce training
Independent oversight for CROs, CMOs & testing labs
Certified PMP project management for facility buildout & launches
Lean Six Sigma programs to reduce cost & boost efficiency
Black Belt–led process optimization and waste reduction
Data-driven performance improvement systems
Embedding a culture of continuous improvement across operations
cGMP audits, gap assessments & remediation plans
QA/QC design, SOP writing & training
Process, cleaning & aseptic validation programs
Mock inspections & 483/NOD response strategies
Risk-based QMS development tailored to operations
OOS investigations & ALCOA+ data integrity assurance
Training programs for floor teams & management
Analytical method development, validation & transfer
Bioassay & potency testing for biologics & biosimilars
Stability, impurity & comparability study design
Validation engineering: IQ/OQ/PQ, process, equipment & software
Technology transfer (domestic & international)
End-to-end CMC support from preclinical to commercial phases