Overview Avivia Services
Avivia is not your traditional pharmaceutical development CD(M)O. We are much more than that. Although we do offer the typical ad-hoc analytical and pharmaceutical development services, we often perform full development programs where we take up projects right from start and deliver product solutions custom-made to the needs and interests of our clients. Our approach is fully integrated and combines hands-on pharmaceutical and analytical development work (formulation & CMC) with high-standard regulatory, intellectual property and market access support.
Our expertise and capabilities are centered around the development of value-added generic drugs, life cycle management of branded drug products, and complex formulation and CMC development of new drug products (NCE).
How we work
Before we start any collaboration (being a full development program or a stand-alone service), it is of the utmost importance that we have a thorough understanding about the product itself (including all available data) as well as about the product portfolio and commercial strategy of our client. We therefore start every interaction with one or more face-to-face or telephone meetings in which all such aspects are discussed. Based on the information provided by our client, we investigate internally the different product development strategies in order to make a tailored-made project proposal. Once the proposal is approved by the client and integrated into a formal collaboration agreement, the project is initiated.
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.
We are open to apply different types of commercial collaboration structures. Full development projects can be performed either on a pure fee-for-service basis or through co-development where we provide the services at cost-price and include a single success-driven milestone payment and a small royalty payment. Stand-alone project services are always performed on a fee-for-service basis.
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
Value-added generic development
Avivia offers full product development services to generic drug companies and specialty pharma focused on the development of new improved versions (value-added generics or generic plus) of established drug products. Typically, our clients approach us with a specific development request but occasionally, we are also asked to investigate and propose new product opportunities based on the existing drug portfolio of our clients. Although in general the overall aim of value-added generic development projects is focused on improving the safety, efficacy and/or the ease of administration, we are also specialized in executing development programs where the primary or sole objective is the evasion of existing product patents.
Life cycle management of branded products
Our ‘life cycle management’ development services are focused on maximizing the value of your drug during its product life cycle. Typically, we are asked by pharmaceutical and biotech companies to develop new product formulations of branded drugs to anticipate on patent expiries, generic competition and profit erosions. Besides hands-on formulation and CMC development work, we also provide specialized analytical, regulatory, intellectual property and competitive intelligence solutions in order to proactively plan your molecule’s path to success from the start.
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 has access to a great team of pharmaceutical and analytical R&D professionals as well as to state-of-the-art laboratory infrastructure and equipment. We have also developed a large network or preferred partners in other fields such as pre-clinical development, GMP manufacturing and regulatory affairs. If relevant, we can always make use of their expertise and capacity to further optimize and accelerate customer projects.
It’s great to have friends!
Avivia to kick-start a development
In many of the projects we encounter, the development has derailed or – in the worst case and despite all previous efforts – has reached a dead end. We are known for our ability to see through the results and to bring up new ways of approaching the project leading to commercial success. Is it our product-driven mindset that makes the difference? Is it our interdisciplinary development approach or our unique technology capacities and experience?
Hard to say but we are very proud that we often succeed where others have failed before!
Avivia to get you back on track
We like to get involved right from the start of a development project and work closely together with our clients and partners on transforming the idea into a product with a solid and commercially viable target product profile (TPP). We set the bar high but always work step by step with a clear focus on reaching the required end-result in the most efficient and cost-effective way possible.
Contact us and let’s see how we can work together on putting your ideas into practice!
