Selecting the right CDMO is one of the most important choices a biotech or pharma team will make. The right partner helps you move efficiently toward IND or IMPD, safeguard quality, and anticipate regulatory needs before they become roadblocks. The wrong one can mean delays, rising costs, and lost momentum.
At Exemplify BioPharma, a Symeres company, we’ve seen how easily programs can be set back when communication, scope, or regulatory expectations aren’t aligned. In fact, industry studies show that outsourcing challenges are among the top causes of missed development timelines.¹
Drawing on more than 30 years of integrated drug development and CMC experience across the Symeres network, this paper highlights the red flags that most often derail outsourced programs—and how to spot and prevent them before they impact your success.
Gated content
Experience a deeper understanding of this content by completing the form below.
Resources we think you'll love
Blog
When a clean PK profile is actually a warning sign
A clean pharmacokinetics profile is often seen as a green light. But in practice, overly tidy PK data can hide analytical artefacts, non-linear behaviour, or poorly understood clearance mechanisms that surface later at significant cost.
Blog
CDMO red flags you can’t ignore: Communication breakdowns
Communication breakdowns rarely start as major problems, but small gaps in coordination can quietly slow progress and erode trust in CDMO partnerships.
Blog
CDMO red flags you can’t ignore: Capacity constraints and resource stretch
Part 4: When “Too Busy” Becomes a Business Risk Even the most capable CDMO cannot deliver high-quality work if it is stretched too thin. As demand for outsourcing continues to rise across the life sciences sector, many CDMOs are operating near or beyond capacity. For pharma and biotech companies, this creates a silent but serious […]
Blog
CDMO red flags you can’t ignore: Regulatory shortfalls and misalignment
Part 3: Could Regulatory Misalignment Be Delaying Your Submission? A CDMO can have the best scientists, excellent facilities, and strong technical execution, yet still fall short when it comes to regulatory alignment. This disconnect between scientific performance and regulatory readiness is one of the most damaging red flags in drug development as it could delay […]
Blog
CDMO red flags you can’t ignore: Underestimating technology transfer complexity
Part 2: Why “Scale-Up” Isn’t Just a Bigger Batch Transitioning a process from discovery scale to GMP manufacturing is almost never straightforward. What runs smoothly at 100 milligrams in the lab can behave very differently at the kilogram scale. Yet too many programs falter because the complexity of this transition is underestimated or treated as […]
Blog
O.N.E Symeres: A practical approach to real-world drug development
No drug development program runs perfectly. Chemistry misbehaves, funding shifts, and timelines tighten. But what defines a reliable partner is how they respond. O.N.E Symeres is the framework we use to keep projects moving through uncertainty: openness, nimbleness, and expertise.
Blog
CDMO red flags you can’t ignore: Undefined or shifting project scope
Part 1: Is an Undefined Scope Putting Your Project at Risk? Selecting the right CDMO is one of the most important decisions in drug development. Yet even experienced biotechs and pharma companies can find themselves trapped in projects where the initial excitement gives way to frustration, and one of the most common culprits is a […]
Whitepaper
Accelerating chemical innovation: Unveiling Symeres’ parallel chemistry
By combining automation, data-driven design, and deep synthetic expertise, Symeres is redefining how chemists generate and optimize compound libraries, bringing speed, scalability, and creativity to modern drug discovery.
Webinar | On-demand
From racemic to pure the art and science of enantiomer separation
From the classical and Dutch resolution methods to preferential crystallization and deracemization, learn the best ways to obtain your desired purity!
Whitepaper
IND & IMPD enabling developability roadmap
Drug discovery and development is a complex and iterative process that involves the identification, design, development, testing, and approval of new pharmaceutical drugs for use in patients. It encompasses a series of scientific, regulatory, and commercial activities aimed at discovering and bringing safe and effective medicines to the market. A key milestone in this process […]
Whitepaper
Innovations in unnatural amino acids: Advancing functional diversity and applications
Unnatural amino acids enable groundbreaking advancements in drug discovery, biomaterials, and peptide design by introducing novel chemical functionalities that enhance stability, specificity, and bioactivity. This whitepaper highlights Symeres’ expertise in synthesizing unnatural amino acids, including side-chain modifications, N-functionalization, and cyclic variants, for applications in pharmaceuticals, diagnostics, and materials science. Utilizing advanced techniques like biocatalysis and […]
Whitepaper
Leveraging copper-catalyzed ullmann-type cross-coupling reactions in PR&D
Our experience in overcoming scaleup challenges and harnessing the benefits of non-noble-metal catalysis makes Symeres the CRO of choice for challenging steps, such as the Ullmann reaction.
Whitepaper
Managing nitrosamines in the pharmaceutical industry: A comprehensive approach
A comprehensive overview of nitrosamine risk assessment, including potential formation, scavenging, and analysis, is described here.
Whitepaper
Optimizing solid-state properties and enhancing API bioavailability through physicochemical prediction
Here at Symeres, we have our new ‘Solid-State Center of Excellence’, and in this whitepaper we describe how we utilize our expertise and novel innovation to further our solid-state capabilities.
Whitepaper
Stable isotope-labeled compounds
Discover how Symeres applies advanced synthetic chemistry and ADME expertise to design, produce, and study stable isotope-labelled compounds that enhance precision in drug development.
Whitepaper
Unlocking the potential of high-throughput screening: Symegold library design and expansion insights
Learn how Symeres combines advanced chemistry platforms and deep discovery expertise to design and expand the SymeGold library, driving more efficient high-throughput screening and smarter hit identification.
Interviews
Insights into drug discovery and development 2025
Here we interview our Director of Medicinal Chemistry, Anita Wegert, for her insights into drug discovery and development for 2025. This interview was conducted an interviewer from the Drug Discovery and Development Europe event and we were able to share our expertise. Curious how our insights can help your next project?
Interviews
Interview with the computer-aided drug design (CADD) department
Our Computer Aided Drug Design department supports our clients' drug discovery projects with some of the best (predictive) software.
Interviews
Meet the Organix Director, Mario Gonzalez
We are pleased to share a conversation with Dr. Mario Gonzalez, a Director at Organix, as he reflects on his journey from Argentina to Massachusetts and provides valuable career insights in celebration of his 30 years with the company.
Interviews
Interview with the new Managing Director of Symeres Groningen
On October 2, Dr Melloney Dröge started in her new role as Managing Director for the Groningen site.
Interviews
An interview with Yadan Chen and Paul O’Shea
We are pleased to introduce the founders of Symeres’ daughter company Exemplify in New Jersey: Yadan Chen, CEO, and Paul O’Shea, Chief Scientific Officer. Who are they? What do they stand for? And how does Exemplify fit with Symeres?
Interviews
An interview with Anu Mahadevan and Paul Blundell
We proudly introduce the founders of Symeres’ daughter company Organix in Boston: Anu Mahadevan, CEO, and Paul Blundell, President at Organix. Who are they? What do they stand for? And how does Organix fit with Symeres?
Blog
Crystalline and liquid crystalline 25-hydroxy-cholest-5-en-3-sulfate sodium and methods for preparing same
Organix, a Symeres company, developed scale up conditions of the synthesis of 25-hydroxy cholesterol 3-monosulfate (sodium salt) from cholesterol. After the protection of the hydroxy group (acetate) and double bond (debromination), the hydroxy group in position 25 was introduced using oxone and trifluoromethylethylketone. Then the 3-hydroxy group and double bond were deprotected, and the resulting […]
Webinar | On-demand
In vivo pharmacokinetic experiments in preclinical drug development
Despite a good part of ADME research in drug discovery and preclinical development can be performed using various in silico or in vitro systems, eventually it becomes necessary to evaluate the pharmacokinetic (PK) profile in animals to elucidate in vivo DMPK properties of the drug candidates.
Webinar | On-demand
Accelerating medicinal chemistry by rapid analoging
Medicinal chemistry is the art of rapidly evolving initial hits to clinical candidates via smart, information driven multiparametric optimization.
Webinar | On-demand
Solid-state chemistry part II: Optimal form selection by controlled crystallization
The webinar by Dr. Edwin Aret of Symeres focuses on advanced strategies for selecting and controlling solid forms of pharmaceutical compounds through crystallization techniques.
Webinar | On-demand
Route scouting for kilogram-scale manufacturing of APIs
The webinar by Dr. Martin Strack provides an in-depth exploration of the strategies and considerations involved in developing scalable synthetic routes for Active Pharmaceutical Ingredients (APIs)
Webinar | On-demand
Solid-state chemistry part I: Introduction
This webinar, presented by solid-state expert Edwin Aret, offers an insightful introduction to the field of solid-state chemistry.
Speak with our experts
Let’s discuss how Symeres can support the discovery and development of your next breakthrough