Celsis Development Services

From discovery through all clinical phases, Celsis Development Services provides a broad range of contract research services that span the drug development process to deliver value to our customers.  We assist pharmaceutical and biotechnology companies during lead optimization by evaluating the in vitro ADME-Tox properties of their drug candidates. Using our catalogue of products and in vitro experimental  systems, we help determine the in vivo behavior of a compound with regard to absorption, metabolism, potential for drug-drug interactions and toxicity.  Beyond discovery and preclinical development, we also offer preformulation services to fully characterize drug molecule physicochemical properties.

From bioanalytical methods development for in vitro and in vivo studies to product characterization for product release and stability monitoring, we provide a comprehensive line of analytical services to better understand the physicochemical and biophysical compound properties.  Our formulation services streamline product development efforts by quickly screening excipients and active ingredients for stability under a variety of conditions.

Our professional staff helps to develop the best and most efficient study strategy and design for our customers.  Our scientists have backgrounds in all phases of pharmaceutical and biotechnology drug development, and they receive continuing education to remain on the cutting edge of scientific innovations and industry practices.  Our focus on quality gives our customers the assurance that their studies are conducted to the highest industry standards and in compliance with the appropriate regulatory guidelines.

At Celsis Development Services, our goal is to help our customers make the best possible drug development program decisions. We see each customer as an opportunity to build a lasting relationship and research partnership. By providing the required knowledge and expertise, we work alongside our customers to efficiently move their products to market.

Specialization in:

ADME-Toxicology

• Drug Metabolism
• Drug-Drug Interactions
• Permeability
• Absorption
• Organ Toxicity
• Plasma Protein Binding

Analytical

• Analytical Methods Development and Validation for:
  • Drug Substance
  • Drug Product
  • Stability
  • Analytical Characterization
• Bioanalytical Methods Development and Validation for:
  • In-vivo studies
  • In-vitro studies

Preformulation and Formulation Development

• Parenterals
• Topical
• Solid Dosage Forms

Expertise with multiple forms of Drug Candidates:

• Small-molecule Compounds
• Recombinant Proteins expressed in different expression systems
• Monoclonal and Polyclonal Antibodies
• Vaccines
  
• Synthetic and Natural Peptides
• Gene Therapy (Plasmid DNA) Products

Professional staff with Ph.D.s in scientific fields including Pharmacology, Toxicology, Biomedical Science, Analytical Chemistry, and Engineering, having extensive experience in pharmaceutical and biotechnology drug development that extends from pre-clinical thru commercial phases.

State-of-the-art instrumentation.

Complete Documentation for Regulatory Submissions including but not limited to INDs, NDAs, ANDAs and BLAs.