Pharma & Fine Chemicals

At Applus+ Laboratories, we offer comprehensive services to the pharma and fine chemicals industry, guiding you through every stage of drug development, qualification and manufacturing. With over 20 years of experience, our team specialises in process scale-up, GMP manufacturing, and analytical testing.

GMP Analytical CRO

Our GMP Analytical Contract Research Organisation (CRO) services support your analytical needs with the highest quality standards. We develop robust analytical methods tailored to your specific APIs or drug products.

We also validate analytical methods in compliance with ICH Q2 guidelines, guaranteeing accuracy and reliability, and include on-routine GMP quality control of raw materials and batch testing, providing consistent quality assurance.

We conduct GMP stability studies of APIs and pharmaceutical products to determine shelf-life and optimal storage conditions. Additionally, we perform dissolution profile testing to evaluate the release rate of drug products, which is critical for bioavailability assessments.

Equipment, Facilities, and Transport Qualification

We provide comprehensive validation and qualification services for your manufacturing plants, equipment, and transport processes, ensuring compliance with regulatory standards. We assist with regulatory affairs, guiding you through the complex regulatory landscape to ensure full compliance.

Our team develops and executes comprehensive validation plans, including:

• Validation Master Plans (VMP)
• Factory Master Plans (VMP)
• Site Acceptance Test (SAT)
• Risk Assessments (RA)
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ).

Our services also include environmental classification and validation of clean rooms, equipment qualification and steam or dry heat sterilization or lyophilization systems.

We perform GMP stability studies of APIs and pharmaceutical products, validating shelf-life and storage conditions. Our team assesses dissolution profiles to ensure consistent product performance.

Robotics

Embracing Industry 4.0, we offer customised robotic solutions to enhance efficiency and minimise contamination risks in pharmaceutical manufacturing. We provide robotics and automation of processes for critical interventions, reducing human error and adhering to GMP Annex I EU guidelines. Our flexible solutions include automated lyophiliser loading systems, improving efficiency and maintaining sterility.

We integrate advanced robotic systems such as Autonomous Mobile Robots (AMRs) and Collaborative Robots (COBOTs), along with AI sensors, to enhance flexibility and productivity. Our expertise extends to electronics, computing, telecommunications, and systems integration, ensuring seamless communication and control across your operations. We offer product control and engineering solutions to enhance quality and compliance. Additionally, we provide UVC robotic solutions for effective pathogen disinfection, reducing microbial contamination risks.

Calibration

We offer comprehensive, high-precision calibration services for industries like Life Sciences, with over 20 years of experience. Our 17025 ENAC accredited labs in Barcelona, A Coruña, Madrid, Navarra, and mobile units provide expert calibration for a wide range of equipment, from temperature and acoustics to electrical and radiofrequency devices. Whether onsite or in our labs, we ensure compliance in every measurement.

Additionally, our legal metrology laboratories are capable of performing the periodic verifications of measuring instruments as established by European and Spanish regulations.

What Are Applus+ Laboratories' Accreditations?

At our facilities, we maintain a rigorous commitment to international quality standards to ensure excellence across all our processes.

GMP for:

• API Manufacturing (Ruesa 4344): Compliant with Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredient (API) production, ensuring safety, consistency, and quality at every stage.
• Quality Control (No. 6783E): Certified for thorough and reliable quality control processes to meet the highest regulatory and industry requirements.

Metrology Accreditations:
We have several laboratories accredited in different magnitudes, under these scopes:

• ISO 17025 No. 93 / LC10.247
• ISO 17025 No. 93 / LC10.017
• ISO 17025 No. 93 / LC10.065
• ISO 17025 No. 93 / LC10.088
• ISO 17025 No. 25 / LC10.151

Regarding legal metrology, we perform Metrological Control of measuring instruments under the scope ISO 17020 No. 424 / EI612.

For the characterisation of clean rooms, biological safety cabinets, laminar flow hoods, and fume hoods, we hold the accreditation ISO 17025 No. 935 / LE1816.

These accreditations underscore our unwavering focus on quality, technical excellence, and customer satisfaction across all operations.

Why Choose Applus+ Laboratories for Pharma and Fine Chemicals?

Choosing Applus+ Laboratories as your partner means benefiting from our extensive experience and comprehensive services. We offer a one-stop-shop solution, from chemical development and process optimisation to equipment qualification and analytical testing. Our skilled team has a proven track record in developing NCEs and generics, contributing to several patents.

We prioritise regulatory compliance, with facilities and processes adhering to GMP standards and a dedicated Quality Assurance department ensuring compliance at every stage. Our flexible and agile approach allows us to adapt to your needs, whether you have short-term projects or complex, long-term collaborations. We emphasise close communication and timely reporting to keep you informed throughout the project.