Chemistry, Manufacturing and Controls (CMC)/Preclinical Consulting
PPD works closely with clients to define and implement chemistry, manufacturing and controls (CMC) and preclinical strategies for successful submissions. Our experienced and certified professionals offer versatility and flexibility to ensure client satisfaction, quality and speed.
CMC Services
CMC/preclinical consulting is available as a customized stand-alone service or a fully integrated element of a multidisciplinary PPD development solution.
PPD’s global resources and expert staff help you create CMC/preclinical programs that are integrated with the clinical and regulatory plans for your drug development program. PPD provides regulatory guidance in developing and validating methods, setting manufacturing specifications and conducting stability studies.
Our regulatory affairs department supports CMC development as follows:
- Identifies contract manufacturers specific to your needs
- Manages contract manufacturing and/or analytical testing of the drug
- Consults on good manufacturing practices (GMP) training, GMP feasibility audits and standard operating procedure (SOP) writing
- Coordinates with contractor(s) to ensure all development work is performed properly and on time
- Prepares quality/CMC submissions for regulatory applications in the common technical document (CTD) format
- Works with regulatory authorities regarding chemistry and manufacturing issues
Drug/Biological Dosage Formulations
PPD staff has extensive experience in all types of drug/biological dosage formulations. For example:
- Oral dosage formulations including tablets and capsules, sterile drug products, topical creams/ointments and suspensions, transdermal patches, and nasal and inhalation products
- Blood products (plasma-derived or recombinant blood products such as immune globulin, clotting factors, etc.)
- Gene therapies (retroviral, lentiviral and adenoviral vectors), somatic cellular and tissue therapies (autologous or allogeneic), xenotransplantation products, ex-vivo transduced cells, and synthetic peptides
- Vaccines (whole cell, killed, component, recombinant and combination), monoclonal antibodies, challenge agents, and synthetic and recombinant peptides from pre-IND through BLA
- Combination products (biologic-drug, drug-device and biologic-device)
Preclinical Services
Our preclinical consulting group provides pharmacological and toxicological assessments, identifies potential safety concerns and provides comprehensive preclinical development advice.
PPD's comprehensive preclinical support for all regulatory submissions includes:
- Preclinical program gap analysis and development
- Comprehensive assessments for estimating safe starting doses for first-in-man (FIM) and first-in-patient (FIP) studies
- Interaction with regulatory agencies, including meeting preparation and facilitation
- Document preparation and review
- Toxicologic risk analysis on extractables and leachables, drug substances and final drug products
