Full product 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.

A typical value-added generic drug development program is structured in multiple phases with relevant go/no-go decision points, and includes the following flow of activities:

Phase Activities Available as stand-alone service
Preparation
(if not yet performed by client)
Freedom To Operate (FTO) and development of patent strategy

Development of pharmaceutical development strategy

Development of manufacturing strategy

Development of regulatory strategy

Literature search and review

R&D Project management R&D

Formulation development + analytical support

Compatibility study

DS/DP: assay development and (pre)validation

DS/DP: purity development (incl. genotoxic and enantiomeric)

DS/DP: forced degradation

DS/DP: identification of related substances

DS/DP: organic volatiles

DS/DP: phys. chem. characterization (morphology, counter ions, etc.)

DS/DP: dissolution/solubility (intrinsic, apparent, instant, 24h, etc)

DP: disintegration

DP: blend and content uniformity

DP: dissolution method development (for DS/DP support and QC)

DS/DP: Analytical method transfer

Excipient characterization (purity, MWD, homogeneity, reactivity, etc.)

Deformulation (quantitative and qualitative, reversed engineering)

Originator characterization

Stability studies (25-55°C/60-90%RH, 5°C, 25°C, 40°C, 60°C, light ICH)

IMPD

CMO selection

Scale up

Stand-alone services


In addition to our full product development services, we also offer tailored-made service solutions focused on the execution of one or more of the above activities.

Case study

Case study

Technical capabilities

Avivia has access to state-of-the-art in-house laboratory infrastructure and equipment. For more information about our laboratory facilities, please click here.

We are able to offer formulation development services for a variety of dosage forms including:
– Tablets, capsules and powders
– Gels and creams
– Liquids, solutions, suspensions and emulsions
– Suppositories and pessaries
– Granules for reconstitution
– Liquids for sterilization
– Drug in capsule/vial

 

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.

 

Contact us

If you are interested to learn more about our development services, feel free to contact us and we would be happy to organize an introductory meeting or call with our team of experts.