Expeditious support services and full CMC development programs

Our flexible and experienced multidisciplinary teams offer fast-track R&D services in addition to comprehensive development programs where we take up projects from the start and deliver products tailored to the needs and interests of our customers. Our approach is fully integrated and combines distinctive hands-on pharmaceutical and analytical development work (formulation & CMC). Besides developing new products clients approach us with development programs that have derailed or – in the worst case and despite all previous efforts – have reached a dead end in their in-house laboratories or other service provider.

We support our customers with early-phase opportunity and strategy evaluation by performing detailed literature searches and reviews, defining freedom to operate and development strategies for regulatory, patents, formulation development and manufacturing.

In the following R&D phase we provide pre-clinical formulations and prototype development in combination with full analytical support.

Pharmaceutical R&D

Having decades of hands-on experience on a wide range of (complex) technologies and a many different types of products, Avivia’s pharmaceutical experts are able to fully execute and/or support the development of any finished dosage form, formula or process, as well as the transfer and scale-up of a developed product to a cGMP manufacturing facility. With our pragmatic and creative development mentality we deliver what a client needs. We perform best by exploring the rationale behind their request in close collaboration with their team.

Analytical R&D

Our analytical experts know what it takes to bring a pharmaceutical product to the market, from discovery, feasibility to cGMP. Having worked with more than 100 unique molecules and even more formulations, we may state that we have faced the most difficult CMC challenges involved. Avivia offers flexible comprehensive characterization, stability, forced degradation and compatibility studies, method development and transfer, problem solving and troubleshooting.

Predictive and Biorelevant Dissolution Testing Support

Our dissolution platform takes release testing to the highest level. The experience and knowledge-based platform focuses primarily on supporting formulation development and problem solving. Ideally clinical data is used to tune and validate the dissolution method(s). For us dissolution testing is never a routine test. Our lab is equipped with all relevant dissolution techniques (i.e. USP I, II, III and IV), and more importantly, we know how and when to apply each system in support of formulation development, troubleshooting and optimization.

Excipient Characterization and Deformulation Platform

Avivia has developed an excipient characterization platform to study the purity and to determine functionality related characteristics (FRCs). With this specific knowledge we have been able to find very specific excipient characteristics that are not part of the routine testing and are not featured on a Certificate of Analysis (CoA) but which do have a profound effect on how the excipient functions within the finished dosage. With this know-how, specific excipient batches, grades or manufacturers can be selected to design pharmaceutical formulations with improved, particular or unique characteristics.

Team work

At Avivia we work in small multidisciplinary expert teams, allowing the analytical researcher to be directly involved in the process of formulation development. This rare approach results in an extremely efficient setting.
For example: the knowledgeable researcher can develop effective dissolution methods, and significantly more important information can be derived from each dissolution test. Educated observations made by the researcher during and at the end of the dissolution test provide valuable data about disintegration, hydration, swelling, erosion, particle size, granulation and coating properties, floating, cone formation, sticking, etc. Discussing these observations during interactions with the pharmaceutical developer offers additional guidance in the evaluation of dissolution profiles, release mechanisms, excipient performance and setting process parameters.

Transfer to cGMP
In the final phase Avivia takes care of the investigational medicinal product dossier (IMPD), analytical method transfer, CMO selection and scale-up.