CMC Development
With a PharmD and PhD in Pharmaceutical Science in ophthalmology, I specialize in the development of personalized formulations for the eye.
Our Areas of CMC Development Services
Liquid forms:
Semi-solids:
Solids:
Our Tailored CMC Development Services
Explore a wide range of services tailored to your needs.
Aseptic manufacturing
Aseptic manufacturing using Blow-Fill-Seal (BFS) technology for eye drops involves a specialized process to ensure the sterile production of liquid medications. BFS is a highly automated manufacturing process used to produce sterile liquid-filled monodoses. It involves three main steps: blow molding, filling, and sealing. We help you develop the batch records, quality agreement, cleaning validation process, quality controls, aseptic filling validation.
Stability plan
It is crucial to establish realistic development specifications and a stability plan to accompany both your non-clinical and clinical development activities. Assessing the development of related analytical methods, degradation products, residual solvents, and impurities early on in the stability plan is imperative. This proactive approach ensures compliance with the latest ICH guidelines, thereby maximizing the probability of success.
GMP Clinical batches
GMP batches are mandatory for clinical trials to uphold patient safety, ensure data integrity, comply with regulatory standards, integrate with GCP guidelines, and maintain product quality and stability. GMP planning starts early in the development process. We help you identify flexible manufacturers who can work on relatively small batch size within a reasonable timeframe. A QP is internally available for QP release. We support alignment of GMP activities with stability planning and execution.
IMPD
The Investigational Medicinal Product Dossier (IMPD) is a critical document that provides comprehensive information on the quality, manufacture, and control of investigational medicinal products intended for use in clinical trials. It plays a vital role in regulatory compliance, product quality and safety, risk assessment and mitigation, clinical trial design and conduct, and promoting transparency and accountability in clinical research. I will guide you in the writing of the IMPD and how to connect these activities with the eCTD Module 3 Quality.
eCTD Module 3 Quality
Our eCTD Module 3 Quality service ensures the seamless preparation and submission of high-quality regulatory documents, meeting the stringent standards set forth by regulatory authorities. Compliant with ICH guidelines, our service guarantees the accuracy, consistency, and completeness of your regulatory submissions.
We offer comprehensive support throughout the entire document lifecycle, from initial planning and content creation to final submission and post-approval maintenance. Our team of expert regulatory professionals, with extensive experience across various indications, ensures that your documents adhere to regulatory requirements and reflect the highest standards of quality.
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Join us in shaping the future of Product Development in Ophthalmology.