BiotechGo Consulting
BiotechGo provides scientific, regulatory, and strategic consulting services for biotech companies, with a track record of over 30 INDs and 200 GLP toxicology studies. The company specializes in managing drug development programs from preclinical stages into IND and clinical phases, offering tailored support in toxicology, regulatory strategy, China CRO outsourcing, virtual R&D operations, and program management. Based in Beijing, with expertise in working with CROs and CDMOs in China, India, and Australia, BiotechGo aims to help emerging biotech companies accelerate their development timelines and reduce R&D costs.
Industries
Nr. of Employees
small (1-50)
BiotechGo Consulting
Solana Beach, California, United States, North America
Services
Comprehensive planning and execution of IND-enabling packages, regulatory strategy, data package planning and eCTD section drafting for early-stage programs across multiple modalities.
Hands-on strategic guidance and program leadership from seed financing through signal-generating Phase 1/2 trials and exit, including milestone definition, budgeting and timeline optimization.
Board-certified toxicology expertise for nonclinical safety assessment, study design, monitoring and interpretation; support for regulatory inspections and agency engagement including special designations.
Identification, qualification and management of CROs in China and APAC; GLP audits, on-site monitoring, data review and vendor coordination to ensure quality and regulatory alignment.
Comprehensive planning and execution of IND-enabling packages, regulatory strategy, data package planning and eCTD section drafting for early-stage programs across multiple modalities.
Hands-on strategic guidance and program leadership from seed financing through signal-generating Phase 1/2 trials and exit, including milestone definition, budgeting and timeline optimization.
Board-certified toxicology expertise for nonclinical safety assessment, study design, monitoring and interpretation; support for regulatory inspections and agency engagement including special designations.
Identification, qualification and management of CROs in China and APAC; GLP audits, on-site monitoring, data review and vendor coordination to ensure quality and regulatory alignment.
Expertise Areas
- IND-enabling development and submission
- Nonclinical toxicology and safety assessment
- GLP CRO auditing and on-site study monitoring
- Regulatory strategy and agency meeting management
Key Technologies
- GLP toxicology studies
- Nonclinical pharmacology studies
- ADME studies
- In silico, in vitro and in vivo toxicology strategies
News & Updates
Track record of 30+ INDs and 200+ GLP toxicology studies
BiotechGo has successfully supported over 30 IND submissions and conducted more than 200 GLP toxicology studies, demonstrating extensive experience in drug development support.
Track record of 30+ INDs and 200+ GLP toxicology studies
BiotechGo has successfully supported over 30 IND submissions and conducted more than 200 GLP toxicology studies, demonstrating extensive experience in drug development support.