Global manufacturers trust Element’s expert scientists to provide industry-specific insight and thorough chemistry, manufacturing and controls (CMC) testing and lab services to support the development, clinical-scale manufacturing, regulatory submissions, post-approval and life cycle management of small and large molecule drug products.
Chemistry, manufacturing and controls (CMC) is a fundamental part of both small and large molecule product regulatory filings, as CMC maintains the connection in quality between the drug product used in clinical studies and the marketed drug. A robust CMC regulatory strategy needs to be applied throughout the entire product lifecycle, from drug candidate selection through post-approval and beyond.
Extensive regulatory requirements and filing pathways expertise
- 351(a) Biologics license application (BLA) for innovator biologics
- 351(k) Pathway for biosimilars and interchangeable biologics
- NDA (New drug application)
- 505(b)(1) Investigational new drug (IND) application
- 505 (b)(2) New chemical entity (NCE) pathway
- 505(j) Abbreviated new drug product (ANDA) for generic drugs
- OTC (Monograph-based or IND-based)
- INAD (Investigational new animal drug)
- NADA (New animal drug application)
- ANANDA (Abbreviated new animal drug pathway for generic new animal drugs)
- CNADA (Conditional approval for new animal drugs)
The Element advantage
With our expertly equipped laboratories, deep bench of technical and regulatory knowledge and wide-ranging capabilities, Element has the resources and know-how to provide comprehensive CMC support throughout the entire product life cycle. Our diverse team of dedicated, highly qualified and experienced scientists and technical leaders provide comprehensive CMC testing services that support all stages of Chemistry, Manufacturing and Controls (CMC) for both small and large molecule therapies. Regardless of your challenges, Element is the partner you need to advance your therapeutic and biopharmaceutical product regulatory submissions.
To learn more about the analytical services we provide for Chemistry, Manufacturing and Controls (CMC), or to speak with one of our experts, contact us today.
More from Element
Pharmaceutical Pre-Formulation & Formulation Development Services
Element’s pre-formulation and formulation development services help enhance delivery performance and stability of your parenteral, ophthalmic, and topical drug products.
Pharmaceutical Testing
Element’s pharmaceutical laboratories provide specialist pharmaceutical testing services, including chemical, physical, microbial, and stability testing on a vast array of products, from raw materials to finished products.
Biopharmaceuticals and Biologics Analysis
Element’s significant expertise in all stages of biologics R&D, from in-house protein biochemistry and molecular biology to cellular biology and QC experience, supports the entire product development life cycle.
Drug Discovery and Development
Discover active drug candidates faster and accelerate time to market with Element's integrated CDMO services platform that supports the entire development lifecycle.