Every second counts for your medicine to reach the market, save lives, and improve people's well-being

Solitek Pharma, Drug Development Preclinical Services

Experts in Solid State and API Development in Preclinical

+ 50 Years of Experience

More than 50 years of accumulated experience adding value to the pharmaceutical industry.

+ 40 Years of Solid State:

More than 40 years dedicated to solid state, its development and optimization.

+ 1000 Projects Executed

Leading work teams in more than 1000 executed projects.

Talented Team

Scientists with a proven track record in solid state development, CMC, and complex problem solving.

Proprietary Tools

Optimized protocols and internal know-how to accelerate decisions and reduce uncertainty

Solid-state development and preclinical formulation services are critical for the development of new drugs and the improvement of existing ones. Regulatory authorities require tight controls on novel drug candidates prior to their progression into clinical trials involving human subjects.

In this context, engaging a specialized company like Solitek Pharma, with its extensive experience and proven track record, provides an initial assurance for minimizing operational risks, reducing project timelines, optimizing investment, and accessing expert knowledge and guidance at every stage of the optimization process, in every challenge.

We deliver flexible and high-quality solutions to pharmaceutical, biotechnology, and generic drug companies, supporting the transition from late-stage drug discovery through early clinical development and late-phase manufacturing. Our expertise ensures optimisation and control of the solid state and physical properties of active pharmaceutical ingredients.

Pharmaceutical Development Services · Solitek Pharma

Quality, Innovation and Safety in Solid Form Phases

Quizás has venido aquí porque sabes que:

Every month lost in the preclinical development delays trials, investment opportunities, and key decisions.
A poor selection of solid form can ruin years of work.
Unoptimized crystallization processes can lead to increased variability, operational setbacks, and a lack of internal confidence.
Poorly documented solid state decisions put the drug at regulatory risk from the start
Inconsistent results lead to delayed decisions and the loss of your partners’ trust
Without a robust solid form strategy, you are increasing the risk of selecting an unsuitable polymorph, salt, or cocrystal.
Investors, partners and management expect clear and fast, evidence-based decisions, not uncertainty.
Your project is advancing, but you're not taking advantage of new intellectual property opportunities.

At Solitek Pharma, we work to ensure that none of this happens in the development of your program.

Solid Form Services Experts · Solitek Pharma

We can Help you with the following Specialized Services:

Crystallization Process

Crystallization processes built for robustness and scale
Consistent batch-to-batch reproducibility
Control of particle size and morphology
Scale up optimization
Plant-ready technology transfer
Designed for real-world manufacturing, not just the lab.

Enabling Formulation

Early-stage, developable formulation design
Preclinical studies and first effective trials
Assessing the impact of solid form on formulation performance
Early identification of bioavailability risks
CMC-driven formulation strategy
Formulations that enable progress without constraining later development

Solid State Characterization

Unambiguous identification of solid forms and polymorphs
Assessment and quantification of crystallinity and amorphous content
Detection of solvates, hydrates, and solid-state impurities
Short and long-term solid-state stability studies
Advanced analytical techniques for precise measurement
Clear, actionable data to support downstream development

Solid Form Screening

Selecting the right solid form from the start
Systematic solid-form screening
Comparative assessment of stability and processability
Risk-based selection for long-term stability and performance
Support for confident early decision-making
Fewer changes. More control.

Computational Solid – State

Virtual cocrystal screening
Polymorphic landscape review
Identifying which experiments add value, and which can be avoided
Using predictions to focus development on the most promising options
Optimizing development time and cost
Early identification of solid-form risks

Pharmaceutical Development Consulting

Specialized technical training in API solid-state science
Expert consulting on specific development challenges
Support for R&D, CMC, and formulation teams
Independent review of risks and critical decisions
Practical, actionable knowledge transfer
Designed to strengthen internal teams, not replace them

Preclinical Development Services

What Benefits do you get with Our Services?

Security

You minimize the risks of solid form failure

Acceleration

You accelerate your preclinical and clinical development

Savings

You save time and money with safe decisions

Regulation

You minimize regulatory risks

Replicate

You achieve reproducible crystallization

bioavailability

You gain better control over bioavailability and variability

Scalability

You get a solid, stable, and scalable form

Knowledge

Strengthen your internal teams with solid-state expertise

What Our Clients Think

"The team at Solitek is world-class. Experts in their field and with a customer-focused attitude, they have supported us on multiple solid state projects over the years, consistently delivering both in terms of technical execution and clean project management and reporting”.

Anthony Debono

Head of R&D API – Medichem, SA

"Solitek provided a highly professional and efficient service, supporting the scale-up process with clear communication, technical expertise, and reliable results".

Marta Monjo

Full Professor at Universitat de Les Illes Balears

“Trabajar con Solitek ha sido un placer. El reto técnico al que se enfrentaban era muy complejo y lo resolvieron con optimismo, eficiencia y rapidez. Colaborar con ellos resultó sencillo y ágil. Su conocimiento técnico y su excelente actitud para afrontar y superar desafíos los convierten en un aliado clave para nuestros proyectos en estado sólido y polimorfismo.”

R&D Director

CDMO & Generics Company

‘Efficient, comprehensive, and budget-friendly, Solitek delivered results that exceeded expectations by identifying polymorphs overlooked by another lab. Their expertise gives me peace of mind when outsourcing my projects.’

Wen Chen

Head of CMC at Eccogene, Inc.

About Solitek Pharma, Solid State API Drug Development

Your Trusted Solid-State Experts

Solitek Pharma se creó para reducir el riesgo y prevenir costosos fracasos en el desarrollo de fármacos de molécula pequeña, basándose en más de 50 años de experiencia combinada en la industria farmacéutica , de los cuales más de 40 se han centrado en el estado sólido .

Nuestra experiencia se ha forjado en compañías farmacéuticas de renombre internacional como GSK, Johnson Matthey y Almac, referentes españoles como Esteve y Medichem, y proveedores especializados en servicios de estado sólido como Pharmorphix y Enantia.

Hemos contribuido a más de 1.000 programas de desarrollo de fármacos , lo que nos permite abordar los proyectos con una perspectiva práctica sobre lo que realmente importa, es decir, qué se necesita lograr y decidir en cada etapa.

Nuestra empresa actual, Solitek Pharma, fue fundada en 2021 y tiene su sede en el Parc Científic de Barcelona, un centro neurálgico para las operaciones y para la atracción de talento especializado en nuestro sector.

Somos un equipo ágil de expertos que trabaja en estrecha colaboración con los clientes, integrándose como una extensión de sus equipos de desarrollo. Nos centramos en las necesidades actuales, ayudando a que los programas avancen con menor riesgo y mayor valor para futuros socios.

Working Together and Strategic Partners

The Value of Experience

Preclinical Drug Development

When does it Make Sense to Work with Us?

APIs in late discovery, preclinical, or early clinical development
Solid-state stability or variability challenges
Development of new solid forms
Optimization of existing processes
Preparing for scale-up or regulatory submissions
We integrate into your team when you need us

Solid Form and APIs Development

Why Choose Us? Our Guarantees

Proven API solid-state expertise

A scientific, pragmatic approach

Capability to handle complex programs

Clear, proactive communication

Data-backed recommendations

Fluent collaboration with technical teams

Proprietary know-how and in-house tools

Contact Solitek Pharma

Book an initial introductory meeting with our expert team—the team that will help you solve your challenges, accelerate progress, and make critical decisions with confidence.

Data Protection

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