Development and Contract Research
Avivia is an independent pharmaceutical development contract organization in the Netherlands (EU) that offers a unique complementary range of pharmaceutical services in the field of:
We serve your organization
Generic drug companies, universities, big pharma, excipient manufacturers, hospitals, specialty pharma, small drug development organizations and even investment firms … our customer base is very diverse.
Our pharmaceutical development and technology expertise and capabilities are centered around the development of generics, life cycle management of branded medicines, and complex formulation and chemistry, manufacturing and control (CMC) development of finished dosage forms based on new chemical entities (NCEs).
From life cycle management to new chemical entities
From ad-hoc pharmaceutical development services to full CMC development programs
Expeditious support services and full CMC development programs
We support our customers with early-phase pharmaceutical opportunity and strategy evaluation by performing detailed literature searches and reviews, defining freedom to operate and pharmaceutical development strategies for regulatory, patents, formulation development and manufacturing.
In the following pharmaceutical R&D phase we provide pre-clinical formulations and prototype development in combination with full analytical support.
Pharmaceutical Development Services
Analytical R&D Services
Predictive and Biorelevant Dissolution Testing Services
Excipient Characterization and Deformulation Services
Avivia has developed an excipient characterization services to study the chemical composition and purity of excipients 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.
At Avivia we work in small multidisciplinary pharmaceutical expert teams, allowing the analytical researcher to be directly involved in the process of pharmaceutical 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. Avivia has a flexible small-scale pharmaceutical GMP production area with state-of-the-art equipment.