CMC/Toxicology Consulting

PPD’s experienced professionals work closely with you to define and implement chemistry, manufacturing and controls (CMC) and toxicology (Tox) strategies for successful submissions. Our global resources and expert staff help you create CMC/Tox programs that are fully integrated with the clinical and regulatory plans for your drug development program.

CMC/Tox consulting is available as customized stand-alone services or fully-integrated into a multidisciplinary PPD development solution with global resources. Our experienced and certified professionals offer versatility and flexibility to ensure client satisfaction, quality and speed. Streamlined procedures provide rapid turnaround of contracts, enabling quick starts.

CMC Services

Working with your manufacturing facilities, PPD provides regulatory guidance in setting manufacturing specifications, method development and validation, and conducting stability studies. We also identify contract manufacturers and arrange contract laboratory services.

Our regulatory affairs department supports CMC development to:

Identify contract manufacturers specific to your needs
Manage contract manufacturing and/or analytical testing of the drug substance or drug product
Consult on good manufacturing practices (GMP) training, GMP feasibility audits and standard operating procedure (SOP) writing
Coordinate with contractor(s) to ensure all development work is performed properly and in a timely manner
Prepare quality/CMC summaries for regulatory submissions
Work 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)

Toxicology Services

Our preclinical toxicology consulting group provides toxicological and safety assessments, identifies potential safety concerns, and provides comprehensive toxicology and preclinical development advice.

PPD’s comprehensive preclinical toxicology 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 participation
Document preparation and review
Toxicologic risk analysis on extractables and leachables, drug substances and final drug products