LBG Pharma
Our team of experts provides comprehensive end-to-end support for your pharmaceutical product development efforts—from process design and development to technology transfer, to vendor selection and outsourcing, to manufacturing, to regulatory strategy, to clinical development. Consider LBG your trusted partner throughout the entire process.
Our experienced consultants each have an average of more than 20 years of experience in the Pharmaceutical industry, from Development, Operations, Technical Services, Quality Assurance, Quality Control, Compliance, and Auditing. We work with a variety of compounds, including synthetic peptides and oligonucleotides, recombinant proteins and antibodies, and aseptically-manufactured materials.
Our CMC team provides expertise in formulation and design, scale-up, technical transfer, CDMO selection, technical design, and protocol review, and our experience spans API, Drug Substance, and Drug Product activities. Key experience includes the establishment of best-in-class technical transfer and validation strategy to meet industry guidelines. In addition, we have proficiency working with CDMOs and laboratory sourcing for manufacturing, scale-up, filling, and packaging needs. We also offer other relevant functional expertise, including capabilities in preclinical development, clinical development and regulatory strategy.
Our team is comprised of highly trained professionals who have extensive experience working through the development, licensure, and commercialization process, and many of our team members have many years of experience in their specific area of expertise. Our team of experts can effectively and efficiently lead or assist your team in the development of new pharmaceutical products, and we customize our approach to address your specific needs and requirements.
Our Pharmaceutical-specific CMC Services include:
- Process Expertise
- Process and Formulation Development
- Scale-up and Technology Transfer
- Process Validation and Reports
- Supplier and CDMO Selection
- Analytical Method Development
- Stability Program Management
- Specification Management and Oversight
- Filling, Packaging, and Labeling
- Cold Chain and Distribution
- Quality and Compliance
- Quality Systems and Management
- PAI Readiness
- Inspection Management
- Supplier Oversight and Audits
- Compliance Management
- Training Programs(GxP)
- Post-Approval Change Management
In addition, the following LBG core services also support our pharmaceutical clients.
- Functional Product Development Expertise
- Chemistry, Manufacturing and Controls (CMC)
- Drug Discovery
- Nonclinical plan development and execution
- Clinical development and clinical study execution
- Regulatory strategy and guidance
- Quality assurance
- Program Management
- Vendor Selection and Management
- Comprehensive Non-dilutive Funding Support
- Opportunity assessment and strategic outreach/positioning
- Proposal/Solution development
- Contract negotiation
- Program and contract management
- Compliance and cost accounting services
- Product development support/expertise
- Overall Agency/NGO relations
- Strategic Consulting Services
- Strategic Planning
- Financial Modeling
- Market Research
- Supply Chain Network Development & Optimization
- Market Access/Launch
- Due Diligence
- Technology Scouting
For more information about how we can support your Pharma efforts, please contact Georgia Sloboda.
