CMC Development and Supplier Management
Pearl Pathways offers integrated Chemistry, Manufacturing and Controls (CMC) development and supplier management services that drive the overall product development process to reach key development milestones. Our experts manage the product lifecycle by helping you make the best choices regarding what you spend to establish and maintain control. Navigating the complexity of CMC manufacturing requires specialized expertise operating within a global quality systems framework.
Pearl Pathways provides CMC programs that are fully integrated with your product’s nonclinical and clinical plans. We possess a wide range of capabilities across the spectrum of new chemical entities (NCEs), generics, biologic products, biosimilars, dietary supplements, cell therapy, and tobacco products.
CMC Development
- Product, analytical and manufacturing process development advice on clients’ portfolio
- Safety, identity, strength, quality, and purity assessment for biologics
- CMC product development consultation from lab to commercial grade product
- Preformulation and formulation development for small and large molecule drugs
- Analytical method development, optimization, and validation
- CMC regulatory affairs support
- Project management
CMC Regulatory Services
- Global, strategic CMC regulatory advice from lab bench to pharmacy shelves
- Preparation and scientific review of IND/CTA/IMPD/NDA/MAA/PMTA and ANDA submissions
- Authoring of annual reports, drug master files, dossier amendments and supplements
- Preparation, publication and submission of electronic common technical document (eCTD) applications
- Direct interactions and negotiations with the U.S. Food and Drug Administration, European Medicines Agency and national agencies as client’s agent to facilitate “best case” outcomes
- Quality by design expertise
Supplier Management
Manufacturers are becoming increasingly aware that supplier management solutions are critical to the quality management process. Vendors providing goods and services to companies operating in regulated environments are only qualified to supply specific products and services. Pearl Pathways will help monitor the performance of your vendors. Our experts monitor supply issues and identify risky vendor situations through a variety of supplier management solutions including:
