Complimenting the drug delivery and formulation development process, 3D Pharma Consulting provides services to assist and manage pharmaceutical manufacturing process design, development, scale-up and technology transfer. We bring knowledge of pharmaceutical engineering, established and emerging manufacturing technologies, risk assessment tools and combine with regulatory and quality considerations to design and develop stage-appropriate solutions. Our Manufacturing Process Development, Scale-up & Technology Transfer services include:
- Process appraisal and gap analysis
- Risk analysis and mitigation strategies
- Process development and scale-up to support progress through preclinical to clinical phases
- Utilisation of Quality-by-Design principles and interpretation and application of ICH-Q8 and -Q9
- Selection and management of CROs and CDMOs for production and analysis of clinical IMP
- Arranging GMP audits of CDMOs
- Coordinating clinical supplies
- Writing of CMC sections of regulatory documents and assistance with scientific advice requests