Transform Your Business with Expert Scientific Consulting

During the development of pharmaceutical products many challenges arise which need to be addressed before the projects can be progressed. The team at Skipping Stone Scientific brings decades of experience which covers everything from initial discovery to commercialized manufacturing processes to ensure that the development of your product can be achieved quickly and effectively. 

 Chemistry, Manufacturing and Controls (CMC) is a critical part of the drug development cycle where an active molecule is developed into a product which can be manufactured to be used clinically or commercially. This process has several stages which the team at Skipping Stone Scientific can guide you through. Typically the process looks at initial development of the active molecule into its optimal form followed by formulation into the desired clinical form and finally manufacturing of the required product. Our team can aid in solving complex development products and even source suitable manufacturing partners who can deliver your product.  

The development of a product initially starts with the optimization of its solid state of a so that all future development can be performed on this form. At Skipping Stone Scientific we have the experience to develop effective screening methods in areas such as polymorphism, salt selection, crystallization and co-crystallization. In addition to designing the screening methods our team can review data and suggest the most suitable forms to progress for further development. 

 The Skipping Stone Scientific team is highly experienced in the formulation development from initial API – Excipient compatibility study design, including stability analysis, through to designing screen for the development of your optimal form. With expertise which covers solid oral dosage (tables, capsules, combined products), solutions, suspensions, nanoparticles and injectables we can aid in the development of your formulated product. 

 A well-designed laboratory space can dramatically improve productivity and increase safety for the team working in it. At Skipping Stone Scientific, we have extensive experience in developing optimal layouts as well as being able to connect you with local qualified builders who can bring your plans to life and even manage construction activities if needed. In addition to the planning lab spaces we can identify types and locations of services to improve the flow of operations in new or existing labs.  We are also experienced in the qualification of laboratory instruments and the accompanying software.  If the vendor's qualification of either of those, does not suit your needs, our team can tailor a process for you qualifying your equipment train. 

Filing regulatory submissions for your products can be a daunting task, however at Skipping Stone Scientific we are able to guide you through this challenging process for each phase of development (Phase I, II, III and commercial). We offer services which range from reviewing completed documents to writing these documents de novo, as well as partnering with you when responding to queries from different regulatory agencies. With our assistance completing these critical documents will be quicker and easier for your team.  

 Generation and review of analytical data is crucial for the development of all pharmaceutical products and equally important is ensuring that you have an optimized method for analysis of samples. To this end Skipping Stone Scientific offers services for the review of data and method development which covers a wide range of analytical techniques, including HPLC, dissolution, FT-IR, UV-Vis, NMR (various experiments), MS, XRPD, DSC & mDSC, Turbidity, TGA, DVS, PSD, ITC, KF | Zeta potential, PLM, HSM, IC, Aqueous solubility, pKa, log P/D, Viscosity and Refractive index. In addition to the analytical data and method development services we can aid you in equipment selection processes. 

Scientific development is a complex process which requires a great deal of documentation in order to be effective and often there is not sufficient time to develop the documentation needed to perform the tasks at hand. We therefore offer customized documentation services to create everything from power point templates to reports and SOP templates using your specific requirements in their creation. We are also able to identify software solutions to aid in your companies’ work processes. 

 The goals of any pharmaceutical development program is to identify a drug and manufacture it on a suitable scale for clinical or commercial production. As setting up a CMC group to perform this work can be a highly costly and time intensive activity for a product where the outcome is unclear Skipping Stone Scientific can help reduce time frames and risks by managing outsourcing of both drug substance and drug product manufacturing processes. With our assistance vendors can be selected, processes identified and the product supplied to clinical sites quickly and effectively. Our experienced team are able to help with any phase of manufacturing from pre-clinical to commercial scale activities. 

 Development of a compound specific dissolution method is often key to a filing and is one of the more scrutinized methods. Depending on the properties of the active ingredient and the excipients, method development can be challenging. The method needs to be developed alongside the optimization of the formulation and manufacturing process.  As such our specialized skills and development experience are a real asset in this process. We have even published on the topic of dissolution. At Skipping Stone Scientific, our highly experienced team can provide custom solutions to even the most complex challenges. By working with your team to fully understand your products, methods can be developed effectively, reducing possible queries that would delay your product’s market approval.