Biotech consultancy - Pharmacology, Toxicology, Preclinical, IND
Scientific, Regulatory and Strategic Consulting for Biotech

Services

Scientific, Regulatory and Strategic Consulting Services for Biotech.

Service Areas 

 

IND-enabling services

  • Early-stage development planning assistance
  • GLP consulting, oversight and compliance
  • Nonclinical program review and strategic support for FDA submissions
  • Safety assessments for biologics, small molecules, devices, biosimilars and combination products
  • Authoring / quality assurance of the toxicology parts in regulatory documents, such as IMPD / IND, CTA, IB, AR / DSUR, BD

REGULATORY TOXICOLOGY

  • Evaluate and provide guidance on all aspects of regulatory strategy for product development
  • Have a strong knowledge of FDA regulations, guidance and expectations based on direct experience
  • Advise on regulatory options and potential pathways.
  • Assist with preparations for FDA and Advisory meetings.
  • Represent clients in interactions with FDA 
  • GLP study (procedure, protocol, report and data audits) and facility audits
  • Remediation services for correcting an FDA Form 483 (or FDA warning letter) fault or deficiency


strategic consulting

  • Evaluate and provide guidance on all aspects of regulatory strategy for product development
  • Advise on regulatory options and potential pathways
  • Assist with preparations for FDA and Advisory meetings
  • Represent clients in interactions with FDA
  • In- and outlicensing / Due Diligence
  • Assistance with financing and funding 

 


toxicology support

  • Safety assessments for biologics, small molecules, devices, biosimilars and combination productsRisk assessment of drug targets
  • Early phase de-risking mitigation and problem solving by custom-made tox strategies (in silicon / in vitro / in vivo)
  • Preparation and evaluation of preclinical safety packages to support various clinical development programs according to current guidelines (FDA, ICH, EMA, CFDA)
  • Planning, monitoring and reviewing general toxicology studies in drug development (GLP and non-GLP)
  • Risk assessment and strategies for qualification of impurities in production and final formulations
  • Occupational Health Categorization / Exposure Limit Assessments


PRECLINICAL PROGRAM MANAGEMENT

  • Serve as a primary point of contact for project coordination
  • Adherence to project timelines, monitoring of project resources, tasks, and budget
  • Integration of multiple functional experts for application review and maintenance
  • Nonclinical pharmacology and toxicology support for drugs and biologics
  • Early-stage development planning assistance
  • Nonclinical program review and strategic support for FDA submissions
  • Review of study protocols and reports for scientific merit and regulatory compliance
  • Nonclinical CRO selection and oversight support

china contact

  • In-sight understanding, independent assessment and flexibility to outsource and monitor studies to the top CROs in China
  • Serve as a primary point of contact for all China-based activities
  • Oversight of China-based contract manufacturing services
  • Qualification of GLP facilities
  • China financing and partnering