Pharmaceutical "Development" Consulting Services

Drive the success of your CMC development programs, mitigate regulatory risk, and strengthen your team's technical judgment with specialized scientific consulting.

Pharmaceutical Development Consulting

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Pharmaceutical Consulting Experts

High-level strategic advisory to unblock complex projects without the need to outsource all lab work.

Independent Technical Review

Expert, unbiased assessment of your data, protocols, or development strategy ahead of critical investment, licensing, or phase-advancement decisions.

Regulatory and Preclinical Alignment

Expert guidance to optimize your development strategies and ensure robust dossiers for FDA or EMA submissions.

40+ Years in Solid-State Science

Over 40 years dedicated to solid-state science, its development, and optimization.

Pharmaceutical Consulting Challenges and Risks

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Lack of In-House Expertise:

Biotech teams lacking dedicated solid-state specialists, for example, in crystalline characterization or advanced preformulation.

Critical Decisions Made Blind:

Difficulty interpreting complex analytical data or choosing the optimal development pathway without an expert second opinion.

Regulatory Delays and Roadblocks:

ncomplete exploration of the solid-form space may leave intellectual property opportunities unidentified.

Lack of Knowledge Transfer:

Internal teams needing ongoing guidance to master crystallization processes and keep pace with emerging regulations.

Overspending on Unnecessary Testing:

Redundant experimental testing driven by a poorly directed development strategy.

Pharmaceutical Industry Consulting Solutions

A) Scientific and Strategic Consulting:

Design of customized roadmaps for solid-state science, preclinical formulation, and crystallization processes.

B) Expert Data Review and Troubleshooting:

In-depth interpretation of analytical reports to resolve technical roadblocks and optimize performance.

C) Tailored Advanced Advisory:

Advanced, tailored, ad hoc advisory sessions suited to your project phase or your team's knowledge needs.

Pharmaceutical Consulting for Companies

Pharmaceutical Regulatory Consulting Services Applied

Biotechs Without an In-House Team:

 Get the executive and technical support in solid-state science and preformulation you need, without expanding your headcount.

CMC Managers and Project Directors:

Rely on a fully trusted external second opinion to validate complex decisions and resolve unforeseen problems.

Generic Pharmaceutical Companies:

Design robust solid-form strategies to accelerate market entry with complete legal certainty.

Testimonials from Pharmaceutical Companies That Have Already Put Their Trust in Solitek

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Neil Sim profile picture
Neil Sim
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At HFR, we have collaborated with Solitek across numerous projects for a number of years. Across all projects that we have collaborated on, I have felt that Solitek really work to fully understand the project from the outset. Victor, Steve and all of the team provide expert knowledge across the solid state landscape and combine a methodical approach with scientific rigour. Their communication and reporting is thorough and clearly presented, providing further value when working on more challenging and complex landscapes.
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Anthony Debono profile picture
Anthony Debono
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I have collaborated directly with Solitek on a number of projects. I highly recommend the team. They combine deep technical expertise and experimental know-how, with an efficient and collaborative customer service. Thanks to their decades of experience in the field they are able to give solid advice on development approaches and are proactive and transparent during project execution.
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Josep Castells profile picture
Josep Castells
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La experiencia con Solitek durante el desarrollo de una molécula activa farmacéuticamente fue muy positiva por su gran profesionalidad y la capacidad de superar los retoques técnicos.
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Adria Espinas Torres profile picture
Adria Espinas Torres
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Great experience working with Solitek from Farmhispania Group on solid-state projects. We collaborated in the development of robust and scalable API crystallization processes and solid form selection and characterization, and they always bring clear, practical solutions. Working with Steve, Víctor, and the rest of the team has been very smooth, with close and easy communication throughout. They are agile, adapt well to project needs, and are strongly results-oriented. Strongly recommended!
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David profile picture
David
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AKL Therapeutics had approached Solitek regarding an unusual and difficult issue associated with a liquid eutectic formulation. Solitek devised a clear and systematic plan of investigations to solve the outstanding problems and were well equipped to conduct the necessary specialist studies in this area. The staff have very good practical knowledge and experience in the area of pharmaceutical formulation development. The investigations Solitek conducted proved to be fully enlightening as to and understanding of key issues involved in the development of a suitable formulation for the concerned molecules. The standard of reporting was excellent with regular scheduled updates that were well communicated by the Solitek team. We would certainly recommend Solitek as a competent and capable partner in the area of pharmaceutical formulation development. John McCrerie for AKL Therapeutics
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Ernesto Durán López profile picture
Ernesto Durán López
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Over the past few years, we have carried out several collaborations with Solitek to address different aspects related to the solid‑state development of pharmaceutical active ingredients. These projects have included salt‑screening studies to modulate API solubility, the exploration of new polymorphic forms and co‑crystals to help overcome IP barriers, and the optimization of process parameters to enhance the robustness of crystallizations at industrial scale. Throughout all these collaborations, the Solitek team has consistently demonstrated strong technical expertise, provided high‑value scientific input, met every agreed timeline, and delivered reports of outstanding quality. Without a doubt, having them by our side when complex challenges arise makes a real difference.
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DBS Chen profile picture
DBS Chen
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With over 20 yrs of outsourcing experience, I have to say Solitek is efficient, comprehensive, and budget-friendly. Their expertise gives me peace of mind when they handle my projects.
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Marta Monjo profile picture
Marta Monjo
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Solitek nos ha ayudado muchísimo en la optimización y el escalado de nuestro proceso. Han demostrado un gran conocimiento técnico y una excelente capacidad para encontrar soluciones prácticas a los retos que han ido surgiendo durante el proyecto. Los estudios de familiarización realizados posteriormente en planta kilo-lab fueron todo un éxito y nos aportaron información muy útil para seguir avanzando. Además, durante todo el proceso de industrialización han seguido brindándonos apoyo y asesoramiento ante cualquier consulta o necesidad que ha surgido, demostrando un gran compromiso con el éxito del proyecto. Ha sido un placer trabajar con un equipo tan profesional, cercano y comprometido. Muchas gracias!
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I Maikel profile picture
I Maikel
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Nuestras colaboraciones con Solitek han sido muy satisfactorias. Su profundo conocimiento del estado sólido, y de los procesos de optimización y escalado han rendido procesos sólidos, fiables, bien documentados y fáciles de transferir. Un placer trabajar con ellos.
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Jacques Alain Bauer profile picture
Jacques Alain Bauer
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The experience with Solitek Pharma projects were perfect, with real-time communication, very flexible collaboration and excellent reporting.
About Solitek Pharma

Consulting Experts for the Pharmaceutical Industry

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Solitek Pharma was founded to reduce risk and prevent costly failures in small molecule drug development, drawing on over 50 years of accumulated experience in the pharmaceutical industry, including more than 40 years focused specifically on solid-state science.

Our expertise was built at internationally recognized pharmaceutical companies such as GSK, Johnson Matthey, and Almac, Spanish companies such as Esteve and Medichem, and specialized solid-state teams such as Pharmorphix and Enantia.

We have participated in more than 1,000 drug development programs, giving us the practical perspective needed to approach each project with a clear sense of what truly needs to be accomplished and decided at every stage.

Our current company, Solitek Pharma, was founded in 2021 and is based at the Barcelona Science Park (Parc Científic de Barcelona), a hub for operations and specialized talent in our sector.

We are an agile team of experts who work closely with our clients, integrating as an extension of their development teams. We focus on what’s needed here and now, helping projects advance with lower risk and greater value for future partners.

"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.

Working Together and Strategic Partners

The Value of Experience in Advanced Computational Solid State
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Our 3-Step Work Process

Expand Your Team's Expertise with Our Vast Experience and Cutting-Edge Technology
STEP 01
Technical Assessment and Scope Definition

We analyze your existing API data, identify crystallization risks, and define key objectives (polymorph, PSD, purity, yield)

STEP 02
Testing Execution and Process Optimization

We execute the work plan at our facilities in the Barcelona Science Park, using advanced characterization and screening tools to reduce risk and optimize every phase of the process.

STEP 03
Clear, Data-Driven Action Plan

We deliver a detailed, actionable technical report, ready for use in regulatory audits or direct transfer to your CDMO.

Frequently Asked Questions About Pharmaceutical Consulting Services

Our services span from discovery and preclinical stages, through CMC development and early clinical trials, to troubleshooting in later-stage programs and life cycle extension for products already on the market.

No. You can rely on our support for specific decisions or problems ,such as an expert second opinion or resolving a particular technical roadblock, without needing to outsource full development.

We act as an expert support partner, providing a valuable second opinion, validating critical CMC decisions, and bringing specialized solid-state expertise that complements your staff.

We combine deep in silico and laboratory-based scientific rigor in solid-state science with extensive experience in advanced formulation and international regulatory compliance (FDA/EMA), ensuring technical decisions have real, commercial impact.

Duration varies with scope — from short, one-off reviews lasting just a few days to ongoing collaborations spanning several months. We design each engagement.

Consulting Services for Pharmaceutical Companies

Need an expert second opinion, or looking to strengthen your team’s technical talent?

Overcome CMC development challenges, eliminate regulatory risk, and make decisions backed by data and scientific confidence with Solitek Pharma’s experts.