CDMO
End-to-End CDMO Solutions Built for Quality, Speed & Compliance
Comprehensive CDMO Services Tailored to Your Molecule’s Journey
We provide a full spectrum of pharmaceutical services designed to meet your specific development and commercialization needs
Manufacturing
Solid Dosage Forms
Our manufacturing capabilities include the production of a wide range of solid oral dosage forms—primarily tablets and capsules. We work with a variety of active pharmaceutical ingredients (APIs) and excipients, using technologies such as:
- Wet granulation: for improved flowability and compressibility of powder blends.
- Roller compaction: a dry granulation method ideal for moisture- or heat-sensitive compounds.
- Direct compression: for streamlined production of stable formulations.
All manufacturing is conducted in GMP-compliant facilities, ensuring consistent quality, full traceability, and regulatory readiness.
Non-Sterile Liquids
We also specialize in the production of non-sterile liquid pharmaceuticals, including syrups, suspensions, and solutions. Our facilities support a wide range of batch sizes and container formats, offering flexibility for both clinical supply and commercial needs. Rigorous in-process controls and environmental monitoring ensure the highest standards of product quality and safety.
Product Development
Our formulation scientists design and optimize dosage forms that are effective, stable, and manufacturable. We support every stage of development—from early-phase prototypes to commercial-ready formulations. Services include:
- Pre-formulation studies
- Excipient compatibility assessments
- Pilot-scale batches and scale-up
- Clinical trial material (CTM) preparation
We tailor our development strategy to the target product profile, therapeutic goals, and regulatory environment, ensuring a smooth path to market.
Analytical Method Development
Robust analytical methods are critical for quality control and regulatory compliance. Our analytical development team designs and optimizes methods for the identification, quantification, and characterization of raw materials, intermediates, and finished products. We emphasize precision, repeatability, and specificity, ensuring methods are suitable for their intended purpose.
Analytical Method Validation
Every analytical method used in a GMP environment must be validated according to ICH and pharmacopoeial guidelines. At Santa pharm, we conduct comprehensive validation protocols to assess parameters such as accuracy, precision, linearity, specificity, robustness, and detection limits. Our validated methods support regulatory submissions and routine quality control.
Batch Testing and Release
Before any batch is released to the market, it undergoes full QC testing against defined specifications. This includes chemical, physical, and microbiological analyses. Our Qualified Persons (QPs) oversee the process to ensure compliance with GMP requirements and European regulations. Each batch is released only after all quality criteria have been met.
QC Chemical/Physical Testing
Our Quality Control laboratories are equipped to perform a wide range of tests, including:
- Assay and content uniformity
- Dissolution and disintegration
- Hardness, friability, and moisture content
- pH and viscosity (for liquids)
We ensure each product meets the highest standards for safety, efficacy, and consistency.
Stability Testing
Stability studies are essential to determine the shelf-life and storage conditions of pharmaceutical products. At Santa pharm, we conduct ICH-guideline stability testing under various environmental conditions (e.g., long-term, accelerated, intermediate). Data generated supports product registration, packaging decisions, and ongoing quality assurance.
Microbiology Method Development and Validation
Microbiological safety is a core component of product quality. We develop and validate microbiological test methods suited to your product matrix and regulatory requirements. Our studies ensure accurate detection of microbial contamination and meet global pharmacopoeial standards.
Microbiology Testing
Our microbiology laboratory offers a complete range of testing services, including:
- Microbial limit testing
- Bioburden and sterility testing (for relevant product categories)
- Endotoxin detection (LAL testing)
- Environmental monitoring and cleanroom qualification
We help ensure the microbiological quality of both products and production environments.
Dissolution Profiling
Dissolution testing is crucial for understanding how a drug releases in the body. We offer customized dissolution profiling to:
- Support bioequivalence studies
- Compare product performance across batches
- Investigate formulation changes or scale-up processes
Our data informs regulatory submissions and ongoing formulation development.
Raw Material Testing
Every production batch begins with verified raw materials. We perform full compendial and custom testing on incoming raw materials to confirm identity, purity, and suitability. This ensures only compliant, qualified materials are used in manufacturing.
Why CDMO ?
Your Trusted CDMO Partner
Integrated Services
From formulation to final product release under one roof.
GMP-Compliant Facilities
Ensuring quality, traceability, and global compliance.
Client-Centric Collaboration
Transparent communication and seamless project management.
Regulatory Expertise
Supporting filings in Europe and beyond with confidence.
Speed to Market
Streamlined processes to accelerate your product launch.
Scientific Excellence
Innovative solutions backed by advanced technologies.
Ready to Collaborate?
Contact Santa Pharm to discuss your CDMO project and bring your pharmaceuticals to market with confidence.
Contact Us