Overview Avivia Services
Avivia supports pharmaceutical companies with integrated drug product development, formulation development, analytical R&D, dissolution testing, excipient analysis and transfer support.
This page gives a practical overview of how we work and which service route best fits your project.
Discuss your project with Avivia
| If your project need is… | Start here |
|---|---|
| Developing or optimizing a formulation | Formulation Development |
| Analytical method development, verification or troubleshooting | Analytical Services |
| Dissolution or release method development | Dissolution Methods |
| Excipient identification, quantification or variability questions | Excipient Analysis / Excipia |
| Reformulation, repurposing or product differentiation | Dedicated Formulation Development |
| Full development program or CMO transfer | Contact Avivia |
How we work
Before starting a project, we align on the product, available data, development objective, regulatory context and commercial strategy. Based on this, we define a practical development plan with clear deliverables, timelines and reporting.
During project execution, we provide regular updates so that the project can be monitored and adapted where needed. Each project is concluded with a report tailored to the objective, whether it is a feasibility assessment, method development package, formulation screening report or transfer-support package.
Typically, our project plans are structured in multiple phases with relevant go/no-go decision points. At pre-defined stages during the execution of the project, the client has the option to decide whether or not to proceed with the current project, and/or to apply alternative development approaches. In this way, we can work together with our clients in the most flexible, cost-efficient and result-oriented way.
A critical factor to ensure a successful execution and completion of our projects is a direct and transparent communication between all parties involved. Before the start of each project, a detailed protocol plan is prepared and agreed upon, while during the project execution itself, frequent updates are provided to our clients allowing close monitoring and/or rapid adaptation of projects. Upon completion of each project, a detailed report is provided to the client.
Non-GMP
GMP
Feasibility phase
Project evaluation
Concept formulation selection
Strategy plan
Development plan
Concept Development
Concept formulations
Develop analytical methods
Test concept formulations
Formulation selection
Product Development
Optimize Formulation
Analytical method optimization
Stability screening
Select CMO
Process Development
Process development
Analytical method verification
Stability batches
Stability testing
GMP
Transfer to CMO
Technology transfer
Analytical method validation
Technical package
Production tech batch
Avivia can work on a stand-alone fee-for-service basis or, for selected full development programs, through alternative collaboration structures. The most suitable model depends on project scope, risk, timeline and commercial potential.
- Stand-alone analytical or formulation support
- Feasibility and troubleshooting projects
- Integrated development programs
- Transfer-support packages
- Selected co-development structures
Value-added generic development
We support generic and specialty pharma companies in developing improved versions of established products, including projects focused on product differentiation, usability, administration route, formulation performance or IP strategy.
Life cycle management of branded products
We support life-cycle management strategies for branded products, including reformulation, product improvement, patent-related development and preparation for generic competition.
Complex formulation/CMC development of NCEs
Avivia is known amongst the drug development community for being able to deliver successful solutions for complex and challenging formulation and CMC development projects. Typically, pharmaceutical companies and smaller drug development firms approach us with development programs that have derailed or, in the worst case and despite all previous efforts, have reached a dead end. Besides hands-on formulation and CMC development work, we also provide specialized regulatory, intellectual property and competitive intelligence solutions in order to proactively plan your molecule’s path to success from the start.
Network to accelerate
Avivia combines in-house pharmaceutical and analytical R&D expertise with access to a trusted network of partners in areas such as preclinical development, GMP manufacturing and regulatory affairs.
Where relevant, this allows us to support development projects beyond the laboratory phase, including CMO selection, technical transfer and follow-up development planning.
Not sure where your project fits?
Many development projects require a combination of formulation, analytical and strategic input. Whether you are starting a new project, improving an existing product or troubleshooting a derailed development program, Avivia can help define the most suitable next step.
Contact Avivia to discuss your development objective.