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.
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.
- Specification setting
- Analytical method development
- Analytical method validation per ICH Q2R1
- Biological characterization
- Cell proliferation and viability
- Safety, sterility and bioburden
- In vitro cellular potency assay method development
- Investigations of aberrant results of unknown impurities
- Biocompatibility testing (ISO 10993-5)
- Q1/Q2(Q3) deformulation
- Impurities characterization (ICH Q3A, Q3B, Q3C, Q3D, and M7 guideline requirements)
- Extractables and leachables (E&L) studies
- Elemental impurities (ICH and USP guidelines)
- Stability testing (ICH Q1A-F) including bracketing and matrixing designs
- Photostability testing (ICH Q1B)
- Finished product batch release testing for a range of substances, including active pharmaceutical ingredients (APIs), investigational medicinal products (IMPs), and finished drug products
- Raw material release testing per pharmacopeia (USP/NF, EP and BP) and internal specifications
- Forced degradation studies
- Compendial monograph testing (USP/NF, EP, and BP)
- Reference standard characterization and management
- Physicochemical characterization
- Particle size
- Solid-state analysis
- CMC documentation package preparation and submission to FDA (BLA, IND, NDA, ANDA and other regulatory pathways)
- Microbiological and small molecule process development
- Small molecule scale-up and manufacturing validation
- Cleaning validation studies and environmental monitoring (EM)
- CMC regulatory strategy development and consulting (phase-appropriate and comprehensive strategy)
- cGMP/QA compliance training (all phases of product development, manufacturing, and quality control)
- Identification and resolution of deficiencies resulting from FDA warning letters, observations, findings, or FDA Form 483 citations
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
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