Are you in Control?
NovusLife can assist the needs of start-up, clinical development, and/or commercial organizations with their CMC needs. We have a broad range of professionals with regulatory as well as quality CMC backgrounds. Should your issues relate to regulatory or technical communication, project management, formulation, analysis or process development NovusLife will help you solve the problem and move on further towards your goals. It is no secret that CMC work is pivotal in getting your IND approved.
Write and compile CMC sections of regulatory communications (briefing documents, IND, NDA)
Write technical sections for regulatory communications or presentations to investors and Boards involving development of drugs, biologics, or combination products
Program design, product development for line extension (product lifecycle management; improved dosage forms)
Selection and management, contract research and contract manufacturing organizations
Preformulation, formulation and dosage form design
Analytical method development
Process design, finished product manufacturing: formulation, filling, and freeze drying for sterile product manufacture
Technology transfer to manufacturing (GMP)
Preparation for site inspections