Unlocking Innovative Solutions in
Formulation Development
Comprehensive Pharmaceutical Development Services
Tailored to Your Needs
Welcome to Avivia, your trusted partner in pharmaceutical development. We specialize in delivering end-to-end solutions to accelerate the drug development process, ensuring efficiency, compliance, and successful outcomes.
Avivia is an independent Pharmaceutical Contract Research Organization in the Netherlands (EU) that offers a unique complementary range of services in the field of Pharmaceutical Formulation Product Development.
Formulation Development
Analytical Services
Dissolution Methods
Excipent Analysis
Formulation Development
From API to Product!
Our comprehensive R&D formulation capabilities combined with our tightly integrated analytical expertise, allow us to support you in advancing your pharmaceutical innovations.
Our knowledge spans a wide range of medicinal dosage forms, providing not only cutting-edge solutions but also tailored problem-solving and troubleshooting strategies. As we are CMO independent, we select the best manufacturing facility for your product.
From reverse engineering, though in-depth research and development, up to small-scale GMP batch manufacturing, we are dedicated to accelerating your product’s journey to market. Partner with Avivia to streamline your drug development process and achieve faster, more efficient outcomes.
Analytical Services
Dissolving your Challenges!
Avivia’s laboratory specializes in delivering comprehensive analytical services crucial for informed decision-making in drug development. We can support you in complex product characterisation, reverse engineering, competitor analysis, and challenging method development.
Our expert team employs a diverse array of state-of-the-art techniques, including chromatography, spectroscopy, mass spectrometry, and more, to ensure the quality, safety, and efficacy of pharmaceutical products.
Dissolution Methods
More than a QC test!
For us, dissolution testing is far from a routine test, it is an essential tool in pharmaceutical formulation development. Dissolution testing should be a discriminatory method that is sensitive to variables affecting release rate and ideally provide predictive value for bio-performance.
Our highly skilled team is dedicated to developing advanced predictive and biorelevant methods, empowering you to make well-informed R&D choices. These sophisticated methods allow our customers to proceed with biological testing with in confidence. We offer a comprehensive range of USP apparatus, from USP I and II through t the more advance III and IV.
Excipent Analysis
For whats not on the COA!
Excipients play a crucial role in pharmaceutical formulations. However, many excipients are natural products, leading to variations in purity and reactivity not only between suppliers but between batchs. These inconsistencies can make it challenging to maintain control over product performance and safety.
Excipia is an excipient characterisation and research service platform, focused on ensuring your excipients are of the right quality. We use our experience, propitiatory expertise and state of the art facilities to characterize and fully identify critical excipient and guarantee the stability and efficacy of your drug products.
Our Services
Comprehensive drug development programs
From product troubleshooting to full service CMC development programs with small-scale GMP production
Avivia offers fast-track pharmaceutical R&D services in addition to comprehensive pharmaceutical development programs where we take up your project from the start and deliver medicinal products tailored to your needs and interest. As versatile as our client projects, our teams are flexible, multidisciplinary, and experienced.
Our approach is fully integrated and combines distinctive hands-on pharmaceutical and analytical development work (formulation, CMC & small scale GMP). In addition to developing new pharmaceutical products, customers approach us with development programs that have derailed or hit a dead end in their own labs or with another 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 subsequent pharmaceutical R&D phase we provide pre-clinical formulations and prototype development in combination with full analytical support.
Active Pharmaceutical Ingredient
The Active Pharmaceutical Ingredient (API) is the part of any drug product that produces the intended effects. Consequently, the API characteristics are crucial for a well performing product. Avivia focuses mainly on small molecules (including peptides) and can improve API properties by altering for example its morphology, stability, solubility and bioavailability.
Pharmaceutical Drug Product
A pharmaceutical drug product consists of (multiple) API(‘s) and excipients and can be developed in a large range of applications. The extensive knowledge of Avivia, release a variety of product possibilities ranging from parenterals to oral solutions, to controlled release tablets, microcapsules, self-emulsifying drug delivery systems (SEDDS) or to implant technology.
Excipient Selection
Excipients are either naturally/naturally derived or synthetic/semi-synthetic. In all cases, they are obtained by chemical processing of a raw material that is usually of animal, vegetable or mineral origin.
With its dedicated platform Excipia, Avivia offers fast and flexible hands-on solutions and troubleshooting services to:
- discover and compare the concealed composition and properties of excipients,
- identify, confirm and quantify individual excipients in a drug product,
- recognize and control unknown Functionality Related Characteristics of excipients in your drug formulation.
- guide excipient manufacturers to select and control their feedstock, production processes and optimize product reliability and consistency
- pick the most appropriate excipient manufacturer, select the most suitable grade, or define customized specifications to control product performance, quality and safety.
Team Work
At Avivia we work in small multidisciplinary pharmaceutical expert teams, allowing the analytical researchers to be directly involved in the process of pharmaceutical formulation development.
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 analytical 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 and small scale GMP production
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.
Why choose us?
Having decades of hands-on pharmaceutical development experience with a wide range of (complex) technologies and the complete scala of finished dosage forms, Avivia’s pharmaceutical experts are able to fully execute and/or support the pharmaceutical development of any finished dosage form, formula or process, as well as the transfer and scale-up of a developed product to an external cGMP manufacturing facility or to our new small-scale pharmaceutical GMP production area.
Once a suitable pharmaceutical formulation has been found our next focus is to support the creation of novel Intellectual Property to protect the product in the market.
With our pragmatic and creative development mentality we deliver what a client needs. We perform best by exploring the rationale behind the request in close collaboration with your team.
In our pharmaceutical lab facilities we can handle almost any small molecule API, including highly potent compounds, hormones, anti-infectives and controlled substances.
We specialize in oral, sublingual, buccal and injectable pharmaceutical dosage forms but also have development projects running intravaginal, intravitreal and topical therapies.
Capabilities
Capabilities
In our pharmaceutical lab facilities we can handle almost any small molecule API, including highly potent compounds, hormones, anti-infectives and controlled substances.
We specialize in oral, sublingual, buccal and injectable pharmaceutical dosage forms but also have development projects running intravaginal, intravitreal and topical therapies.
Technology
An extensive platform of pharmaceutical technologies is present and includes for example aseptic filling, dry/wet granulation, tableting, spray drying, micro-encapsulation, and (hot melt) extrusion. In addition we have a fully equipped analytical laboratory to support the pharmaceutical development.
Contact us
Ready to take the next step in your pharmaceutical development journey? Contact us today to discuss your project requirements and explore how we can help you achieve success.
