Ascendia Pharmaceutical Solutions offers full-spectrum cGMP services that support clients from early-stage formulation through clinical and commercial manufacturing. The company's approach is rooted in a strong quality system, process adaptability, and technical expertise in advanced drug delivery technologies. These capabilities position Ascendia Pharmaceutical Solutions as a specialized partner for pharmaceutical and biotech companies developing complex dosage forms. It also allows us to fulfill our promise of Fast, Flexible and First Time Right.
Strong cGMP Quality Systems Built for Compliance
Ascendia Pharmaceutical Solutions’ approach to cGMP compliance begins with a foundation of comprehensive quality systems. All procedures are documented, trained, and verified through a continuous improvement loop. Deviations, corrective actions, and preventive actions (CAPAs) are managed through formal systems that align with current Good Manufacturing Practices (cGMP).
To support these activities, Ascendia Pharmaceutical Solutions is transitioning from paper-based documentation to an electronic quality management system (QMS). This shift enables greater control over core components of any effective cGMP-compliant operation, including batch records, training logs, deviation handling, and data integrity, .
Audit-Ready Facilities and Continuous Inspection Preparedness
Ascendia Pharmaceutical Solutions’ U.S.-based manufacturing facilities located in the New Jersey Bioscience Center are designed to meet all applicable cGMP requirements. While the company’s current focus is on clinical trial materials, it is actively preparing for commercial production and regulatory inspections.
Client audits are frequent and thorough, with multiple sponsors conducting detailed cGMP inspections each year. These audits serve as real-time validation of Ascendia Pharmaceutical Solutions’ systems, and clients have responded with high confidence in the company’s quality systems. Additionally, internal audits and third-party quality experts are used to benchmark against FDA expectations and ensure readiness for future inspections.
Full-Service cGMP Manufacturing for a Range of Dosage Forms
cGMP services offered by Ascendia Pharmaceutical Solutions span a wide range of pharmaceutical dosage forms. Our teams are expert in:
- Sterile injectables.
- Oral solid dosage forms.
- Nanoparticle formulations, including lipid-based drug delivery systems.
- Long-acting injectables and lyophilized products.
Each product is manufactured under cGMP conditions, with support from initial formulation through IND-enabling batches, Phase 1 to Phase 3 manufacturing, and regulatory documentation preparation.
Solving Bioavailability Challenges with Advanced Technologies
Ascendia Pharmaceutical Solutions’ core strength lies in solving solubility and bioavailability issues for poorly soluble APIs due to our four patented nanotechnologies. Using these in-house solutions allow us to develop advanced nanoemulsions, amorphous solid dispersions, and Self-Emulsifying Drug Delivery Systems (SEDDS) to enhance drug absorption and therapeutic efficacy.
These innovative solutions are implemented under full cGMP controls, enabling clients to bring new therapies to patients faster while maintaining regulatory compliance.
Adaptable cGMP Operations for Complex Development Programs
Unlike other CDMOs focused on high-volume commercial production, Ascendia Pharmaceutical Solutions operates with built-in flexibility. Its quality systems and standard operating procedures (SOPs) are designed to support high-mix, low-volume projects where every product presents a new formulation, delivery challenge, or regulatory pathway.
The team’s adaptability allows for rapid transitions between sterile injectables, oral solids, and complex delivery systems, all under strict cGMP protocols. This operational model ensures that each product is handled with precision and attention to regulatory detail.
Collaboration-driven cGMP Project Execution
Ascendia Pharmaceutical Solutions works closely with clients at every stage of the development and manufacturing process. Weekly meetings, transparent data sharing, and alignment on quality expectations are central to each successful cGMP manufacturing project.
Clients rely on Ascendia Pharmaceutical Solutions to support regulatory submissions by providing validated analytical data, traceable batch records, and documentation aligned with FDA and global regulatory requirements.
Why Choose Ascendia Pharmaceutical Solutions for cGMP Services
Drug developers partner with Ascendia Pharmaceutical Solutions to:
- Manufacture clinical trial materials under full cGMP compliance.
- Transition from early-stage development to commercial readiness.
- Implement complex drug delivery systems in a regulated environment.
- Work with a team experienced in FDA, EMA, and client audit preparation.
Ascendia Pharmaceutical Solutions’ quality-first approach, combined with its technical capabilities, makes it an ideal CDMO for companies developing innovative therapeutics. It is a pillar of our BEST philosophy, which consists of Brilliant technology, Excellent service, Superior quality, and Trust.
Contact Ascendia Pharmaceutical Solutions for cGMP Support
Ascendia Pharmaceutical Solutions provides end-to-end cGMP manufacturing services for complex and high-value drug products. For companies seeking a reliable partner with deep expertise in formulation, compliance, and quality systems, Ascendia Pharmaceutical Solutions offers a clear path to regulatory success.
Schedule a meeting with the Ascendia Pharmaceutical Solutions team to discuss your cGMP manufacturing needs.