Global manufacturers trust Element’s expert scientists to provide industry-specific insight and thorough chemistry, manufacturing and controls (CMC) consulting 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, technical leaders, CMC regulatory specialists and Quality Assurance/GMP-compliance trainers, provide comprehensive consulting 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 consulting and analytical services we provide for Chemistry, Manufacturing and Controls (CMC), or to speak with one of our experts, contact us today.

Comprehensive CMC services and solutions for biologics, small molecule and other drug products

Our consultative approach enables speed to market as our dedicated team of regulatory experts and scientists work in partnership with clients to expeditiously move therapeutics, drug products and vaccines through clinical development, formulation and manufacturing, and provide post-approval support, including post-launch formulation optimization and life cycle management solutions.

Solutions for a variety of drug products

  • Biologics (recombinant proteins, antibodies, oligonucleotides, lentivirus, and AAV)
  • Biosimilars and interchangeable biologics
  • Small molecule drug substance and drug product
  • Generic drugs
  • Innovative and novel products
  • Combination products
  • Over-the-counter (OTC) and monograph drugs
  • Animal drug products

Our team of over 6,000 Engaged Experts in North America, Europe, The Middle East, Australia, Asia and Africa are ready to help you.