Free E-Book
How to select a CDMO for your softgel development
Partnering with the right contract development and manufacturing organization (CDMO) is essential to avoid inefficiencies, increased development costs, and protracted timelines.
This free e-book guides you through the entire CDMO selection process and helps you identify the critical factors that determine development success, ranging from personnel and technical expertise to documentation, intellectual property, and operational flexibility.
What this free e-book covers:
CDMO Selection Process
Understand the systematic approach to defining requirements, pre-screening potential partners, structuring effective RFPs, and conducting thorough evaluations. Our e-book covers every step from initial market research to final decision-making, ensuring you select a partner that meets your technical and business needs.
Documentation and Regulatory Support
Discover how to assess documentation standards, report preparation processes, and internal review procedures. Understand what to look for in a CDMO's regulatory support capabilities, including familiarity with current regulatory expectations and history with regulatory authorities in your target markets.
Personnel ande Technical Expertise
Learn to evaluate the experience level of scientists and project managers, team structure, and project leadership capabilities. Understand how to assess a CDMO's track record with similar softgel developments, their methodology for formulation development, and their approach to knowledge management.
Analytical Expertise and Quality Systems
Learn to evaluate a CDMO's analytical capabilities, including method development, dissolution testing for lipid-based formulations, and stability testing infrastructure. Understand how to assess quality systems, data integrity practices, and compliance track record.
From our e-book:
"A CDMO with specific expertise in this area can make the difference between a successful product launch and a costly development failure. While cost and timeline are important considerations, the 'soft' factors such as personnel experience, technical expertise, documentation quality, analytical capabilities, intellectual property management, and operational flexibility can be equally, if not more, critical to the ultimate success of your project."
Why work with us
Despite the growing importance of outsourcing in pharmaceutical development, CDMO selection for specialized dosage forms remains challenging. Each development project presents unique requirements, demanding expertise in formulation, analytical methods, regulatory affairs, and project management for success. Bringing together the best practices in CDMO selection, we stand as independent experts with real solutions.
Navigate CDMO selection with confidence
Avoid common pitfalls in CDMO partnerships, such as technical knowledge gaps, resource constraints, and communication breakdowns, by adopting a systematic approach to partner selection that considers both technical capabilities and organizational fit.
Make informed outsourcing decisions
We support you in conducting comprehensive requirements analysis, preparing effective RFPs, and evaluating CDMO proposals with an expert eye. Our methodology empowers you to identify the right development partner for your specific product needs.
Establish efficient collaborations
Leverage our specialist knowledge to structure partnerships that minimize risks and maximize efficiency. We help you define clear expectations, establish effective communication channels, and implement robust governance frameworks for your CDMO collaborations.
Partner with specialized softgel expertise
Benefit from our deep understanding of softgel development requirements and CDMO capabilities. We help you identify partners with the right technical expertise, quality systems, and collaborative approach to ensure development success.
Tell us about your project.
Our team of softgel capsule experts is standing by to help you on your journey.