Services and Expertise
Services and Expertise
STRATEGY AND INNOVATION
Scope and detail of the plan is dictated by the client; it is a living document that evolves along with the project. We adapt our strategy in accordance with changing regulatory requirements via:
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Continuous monitoring of regulatory requirements and adapting the plan to reduce development time and ensure optimal presentation of submission to regulatory authorities.
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Providing customized, strategic response to meet our clientsâ goals. Our âlearning/confirmingâ approach to drug development is designed to offer timely, cost-effective and efficient strategies to steer a molecule from discovery to the market.
REGULATORY CONSULTING
Preparation of MAA, BLA or NDA
Clinical Trial Applications (CTAs/IND) and related documents (IMPD, IB,etc).
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 towards marketing approval
Regulatory Support throughout the product development process
SME status and representation
Briefing packages for Scientific Advice/Protocol Assistance or FDA meetings
Participation in Scientific Advice / Protocol Assistance or FDA meetings at all stages of development
Pediatric Investigation Plans (PIPs)
Orphan Medicinal Product Designations (EU) / Orphan Drug Designation (US)
Risk Management Plans (RMPs) and Environmental Risk Assessments (ERAs)
In addition to medical and regulatory expertise we have a body of scientific knowledge that encompasses molecular biology, virology, toxicology, toxicokinetics, non-clinical and clinical pharmacology, technical development and GMP manufacturing.
CMC TECHNICAL DEVELOPMENT
Manufacturing process definition and gap analysis. Pre- and post-process characterization risk assessment
Process characterization planning and execution
Process qualification
Comparability strategy
Identification and selection of appropriate analytical assays, review of protocols, data and validation reports , in-process and batch-release test methods
Ensuring robust, compliant and timely product supply
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Product supply strategy
CDMO Selection, due diligence and Project Management
Technology Transfer and Manufacturing campaign readiness
LCM planning and continuous improvement implementation
Technology licensing assistance
CLINICAL DEVELOPMENT
Design and implementation of clinical development programs
Validation and harmonization of prospective clinical development programs with relevant regulatory authorities
Review and gap analysis of existing clinical development programs and data packages
Protocol design of Phase I, II, III and other related documents (IB, IMPD, ICF).
Monitoring of development progress with the client to guide and manage CMOs/CROs or other development partners
Analysis of clinical data (including PK and PD) and writing or review of ICH clinical study reports
NON-CLINICAL DEVELOPMENT
Design of study protocols for pharmacodynamic, pharmacokinetic, safety, pharmacology and toxicology studies
Continuous follow-up on a study and data analysis to ensure generation of high quality regulatory compliant reports
Preparation of non-clinical parts of various regulatory documents
Document review, due diligence and gap analysis of existing non-clinical development programs and data packages
SPECIFIC EXPERTISE
Therapeutic and diagnostic monoclonal antibodies
Radio-Immuno-Therapeutics (RIT)
Peptides, peptidomimetics
Vaccines: preventive and therapeutic
Cell therapy, allo- and xeno-transplantation,
Blood products including hemoglobin therapeutics
Immediate & prolonged release formulations
New chemical entities
Medical devices
POST-MARKETING SUPPORT
Addressing post-authorization commitments by designing Phase IV study protocols, registries, long-term safety studies and interacting with EU Rapporteurs
Translating MAA/BLA/NDA into marketing documents by preparing publications of key registration studies and presenting data at international conferences and meetings
Providing continued regulatory compliance through line extensions, variations and new indications
Triskel serves as a strategic liaison to connect contract research organizations (CROs), contract manufacturers (CMOs) or other classical service providers, offering consulting services throughout the productâs lifespan â from discovery through to the post-authorization phase