• BioProcess Technology

Accelerating biopharmaceutical process and program development.

BDO’s BioProcess Technology Group (BPTG) is the world leader in providing strategic, technical, regulatory, and business consulting services to the biopharmaceutical industry. We understand first-hand the challenges of developing and commercializing new products and technologies. BPTG provides flexible and responsive consulting services to help you through complex technical and regulatory issues allowing you to achieve your key business milestones.

BPTG offers full-service strategic CMC advisory and technical support across your product life cycle or targeted, short-term consultations (engagements) on specific technical, quality, regulatory, or operational issues. Our consultants are highly experienced thought leaders across various disciplines and provide actionable insight, targeted analyses, and solid strategies to help de-risk the technical, quality, and regulatory challenges of the development and commercialization of our products.

Regardless of your need, our expert team provide you with the thought leadership, integrity, and outstanding service you demand.
 
  • Risk assessment and risk management
  • cGXP compliance assessments
  • IND and BLA filing and amendments
  • PAI readiness assessments and gap analysis
  • cGXP audits
  • Support with resolution of FDA 483s
  • Support with “For Cause” audits and FDA consent decrees
  • Project Management and execution of corrective action plans