Tailored and seamless scientific and legal strategic guidance from molecule to market
Chemical, Pharmaceutical & Biologicals /CMC
• Strategy for Upstream and Downstream process optimisation
• Process Flow diagram; Bottleneck identification; Medium and chromato optimisation; Continuous or Batch process rationale; Wave bag implementation; Cell separation approaches; Buffer consumption; Cleaning issues; Pre-formulation at bulk level; Fill and Finish anticipation; Freeze-drying elimination; Quality attributes
• Process and analytical evolution as a function of clinical phase.
• Viral clearance strategy
• Risk analysis; Animal free components; Viral clearance studies; Validation approach.
• Clinical trial production strategy
• Internal production or Outsourcing; Final Dosage anticipation; Associated devices; Quality progress as a function of clinical trial.
• cGMP assessment of facility
• Flow reviews (raw material, product, equipment, clean/dirty segregation, people, viral segregation);
• Flow and treatment; Air locks, pressure cascade; Air breaks; Risk Analysis (HACCP)
• Engineering review
• Concept and philosophy assessment; Piping & Instrumentation (P&I) Diagram review; Contract review;
• Global planning review, HVAC requirements
• Sizing of manufacturing equipment, Water for Injection production, Steam production
• Documentation review
• Review of FAT and SAT protocols; IQ/OQ protocols; Validation Matrix
• Equipment qualification
• Acceptance criteria review
• Process validation
• PQ philosophy; protocol review; Cleaning validation
• System validation
• PQ WFI, PQ gas, Air treatment; Risk assessment review
• Technology Transfer Assistance
• Protocol and acceptance criteria review; Equipment suitability; Batch record review; Report review
• Technology licensing assistance
• Value analysis; Intellectual property assessment; Negotiation
• Continuous improvement implementation
• Target definition; Performance assessment; Project definition and follow-up
• Capital usage optimisation
• Switch to multi-products operations; Automation versus manpower; Scale –up and/or bottleneck elimination
Triskel's experts can define analytical assays, review protocols, data and validation reports for assays required for:
• characterisation, in-process control and batch-release during manufacturing development or
• non-clinical and clinical studies.
For biologics, this includes assays to determine the immunogenicity of both the medicinal product and its Host-Cell Proteins (HCPs).
Triskel’s staff has the adequate knowledge and expertise to fully prepare in-house all scientific documents which constitute the Modules 2.3 and 3 of MAA, BLA or NDA submissions.
- Design and implementation of clinical development programmes
- Validation and harmonisation of prospective clinical development programmes with relevant regulatory authorities
- Review and gap analysis of existing clinical development programmes and data packages
- Protocol design of Phase I, II and III; IB, IMPD, ICF, CRFs
- Monitoring of development progress through steering committees with the client to guide and monitor CMOs/CROs or other development partners
- Analysis of clinical data (including PK and PD) and writing or review of ICH clinical study report
- Preparation, submission and maintenance of clinical trial applications/INDs
- Preparation of clinical parts of various regulatory documents: Scientific Advice, Investigator Brochure, IMPD, CTD Modules 2.5, 2.7 and 5 of MAA, BLA and NDA
- Support for EU legal representation
- Evaluation of therapeutic areas and potential efficacy of novel medicinal products prior to proof-of-concept
- Strategic planning to obtain best regulatory outcome
- Design of global regulatory strategy for marketing approval
- SME status and representation (Triskel holds SME status in Europe)
- Briefing packages for Scientific Advice/Protocol Assistance or FDA meetings
- Participation in Scientific Advice / Protocol Assistance or FDA meetings at all stages of development
- Paediatric Investigation Plans (PIPs)
- Orphan Medicinal Product Designations (EU) / Orphan Drug Designation (US)
- Clinical Trial Applications (CTAs/IND) and related documents (IMPD, IB, …)
- Preparation of all CTD modules and MAA submission
- Risk Management Plans (RMPs) and Environmental Risk Assessments (ERAs)
- eCTD preparation
- Continued regulatory compliance through line extensions, variations, new indications and post-authorisation commitments
- Post-authorisation commitments by designing Phase IV study protocols, registries, long-term safety studies and interacting with EU Rapporteurs.
- Translating the science (included in the MAA/BLA/NDA) into marketing documents by preparing publications of key registration studies and presenting data at international conferences/meetings.