Seda Clinical Manufacturing Services provides end-to-end Solutions for Clinical Trials. We provide comprehensive services for the establishment, testing, manufacturing, and distribution of oral dosage forms for clinical trials. Our integration with the Pharmaceutical Development Services division ensures a seamless transition into clinical phases, managed by a single, accountable Project Leader.
Manufacturing Services
Our GMP manufacturing capabilities are delivered through 5 grade D cleanrooms, designed to accommodate discrete equipment process chains allowing for flexible, multi-product manufacture to be executed simultaneously, with the highest standards of product containment.
We use globally recognised technology providers such as Bonapace, RoTab, Freund Vector and Procept to deliver complex, scalable oral solid dosage forms.
Our servicesinclude:
- Tablet Manufacture: Small to mid-scale blending, granulation, compression and coating
- Capsule Filling: Solid, liquid and semi-solid formulations, from very small (semi-manual) to mid-scale automated filling.
- Spray drying: Amorphous solid dispersions from aqueous and solvent systems.
We follow a structed New Product Introduction process to ensure a seamless transition from early feasibility to robust clinical manufacture.
Analytical Services
Our analytical and Quality Control services ensure the highest standards of quality and compliance:
- Raw Material Testing: Identity, purity, and potency testing.
- In-Process Control: Real-time sampling and analysis.
- Finished Product Testing: Chemical, physical, and microbiological testing.
- Stability Testing: Determination of shelf life and storage conditions, including long-term, intermediate, and accelerated studies.
- Method Development and Validation: Accurate and reliable testing methods using state-of-the-art equipment and techniques.
- Documentation and Compliance: Comprehensive documentation for all QC activities, ensuring full traceability and compliance with regulatory standards. Our meticulous record-keeping supports audits and inspections, providing peace of mind to our clients.
QA Services
Our experienced Quality Professionals, including Qualified Persons (QPs), work alongside our clients to safeguard product quality, streamline manufacturing processes, and support regulatory submissions. We maintain a modern, fully electronic Pharmaceutical Quality System (PQS) which forms the backbone of our regulatory compliance framework.
Our QA services include:
- Quality Assurance Support: Addressing quality-related issues and ensuring regulatory compliance through documentation review/approval, QP certification/confirmation and regulatory assistance
- Regulatory Compliance: Guidance to help clients meet the requirements of MHRA, FDA, EMA and ICH guidelines, from clinical trial approval to market entry.
- GMP Compliance: Strict adherence to Good Manufacturing Practices (GMP) ensuring that all of our operations meet the highest standards of compliance.
- Documentation Control: Managing the creation, review, and maintenance of all essential documentation for regulatory submissions, including batch records, Standard Operating Procedures (SOPs) and Batch certifications (COAs, COCs).
- Risk Minimisation: Our focus on compliance, documentation, and quality management reduces potential risks, allowing your clinical trials to move forward without unnecessary delays.