Flexible and Bespoke Nonclinical, Safety Toxicology & CMC Expertise as Required
The Peritus Toxicology team has extensive industry and scientific experience – including EU registered toxicologists, CMC specialists, pharmacologists and pre-clinical specialists from industry and clinical research organisations – enabling us to provide expert non-clinical evaluation, strategy development, study design, reporting and pre-clinical / non-clinical gap analysis & CMC services.
Please contact us for support in any non-clinical toxicology and CMC matters related to products and medical devices or if you have more specific issues that you wish to discuss with us.
Nonclinical Inputs for CTDs
Nonclinical Overview CTD Module 2, Section 2.4
Nonclinical Introduction CTD Module 2, Section 2.6.1
Nonclinical Written Summaries CTD Module 2, Section 2.6.2, 2.6.4, 2.6.6
Nonclinical Tabulated Summaries CTD Module 2, Section 2.6.3, 2.6.5, 2.6.7
Nonclinical Studies Reports CTD Module 4
Nonclinical Inputs for Other Common Documents
Investigator’s Brochure
Investigational Medical Product Dossier
Briefing Packages
Special Protocol Assessment
Risk Management Plan
Pediatric Investigation & Study Plans
Reference in other regular reports such as DSURs
Chemistry Manufacturing & Controls (CMC)
Peritus Regulatory team offers technical, strategic regulatory and development support services in CMC.
The CMC team has significant industry experience with biologics (recombinant proteins, monoclonal antibodies, vaccines (both therapeutic and prophylactic), biosimilars, ATMPs (cell, gene and tissue therapies) and small molecules.
The depth of expertise and experience within the CMC team enables Peritus Regulatory to provide bespoke and often innovative approaches to overcome complex issues encountered in product development and challenging of the status quo.
Examples of recent projects:
- Provision of regulatory CMC support for an oncology gene therapy product and various monoclonal antibodies
- Scientific meetings with FDA / EMEA
- MAA preparation for monoclonal antibody products and vaccines (EMA/FDA)
Orphan biologic (breakthrough therapy); providing early phase regulatory support for scientific advice meetings and IND/IMPD writing - Post approval lifecycle regulatory support for vaccines and monoclonal antibodies – including site transfers
- Regulatory strategy and TSE risk assessment for a cancer vaccine in early development
- Set strategy for novel product packaging redesign and subsequent over label
Please call us to see if we can help with your product development CMC requirements.
Bespoke Toxicology Design Services
Study Design
Intermediate Reporting
Study Monitoring Services
Quality Control
Report Review & Evaluation
Nonclinical Advanced Therapy Medicinal Products (ATMPs) Development
Peritus has a network of personnel with experience of non-clinical safety assessment of ATMPs including cell & gene therapy medicinal products and tissue engineered products (TEP)
Meeting with Regulatory Bodies (Attendance as Non-clinical Expert or Presentation)
MHRA
EMEA
FDA
Japan – Pharmaceutical and Food Safety Bureau
Notified Bodies
Expert Pathology Reviews
Non-clinical Regulatory provides pathology slide assessment and reviews
Comparative reviews undertaken