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 and filing of submissions
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Preparation of MAA, BLA or NDA
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Clinical Trial Applications (CTAs/IND) and related documents (IMPD, IB,etc).
Regulatory affairs, Interaction with health authorities worldwide
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Evaluation of therapeutic areas and potential efficacy of novel medicinal products prior to proof-of-concept
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Strategic planning to obtain best regulatory outcome
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Design of global regulatory strategy towards marketing approval
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Regulatory Support throughout the product development process
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SME status and representation
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Briefing packages for Scientific Advice/Protocol Assistance or FDA meetings
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Participation in Scientific Advice / Protocol Assistance or FDA meetings at all stages of development
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Pediatric Investigation Plans (PIPs)
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Orphan Medicinal Product Designations (EU) / Orphan Drug Designation (US)
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Risk Management Plans (RMPs) and Environmental Risk Assessments (ERAs)
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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
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Manufacturing process definition and gap analysis. Pre- and post-process characterization risk assessment
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Process characterization planning and execution
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Process qualification
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Comparability strategy
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Identification and selection of appropriate analytical assays, review of protocols, data and validation reports , in-process and batch-release test methods
GMP readiness and Manufacturing
Ensuring robust, compliant and timely product supply
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Product supply strategy
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CDMO Selection, due diligence and Project Management
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Technology Transfer and Manufacturing campaign readiness
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LCM planning and continuous improvement implementation
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Technology licensing assistance
CLINICAL DEVELOPMENT
We offer a full-range of integrated clinical development services for medicinal products
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Design and implementation of clinical development programs
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Validation and harmonization of prospective clinical development programs with relevant regulatory authorities
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Review and gap analysis of existing clinical development programs and data packages
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Protocol design of Phase I, II, III and other related documents (IB, IMPD, ICF).
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Monitoring of development progress with the client to guide and manage CMOs/CROs or other development partners
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Analysis of clinical data (including PK and PD) and writing or review of ICH clinical study reports
NON-CLINICAL DEVELOPMENT
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Design of study protocols for pharmacodynamic, pharmacokinetic, safety, pharmacology and toxicology studies
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Continuous follow-up on a study and data analysis to ensure generation of high quality regulatory compliant reports
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Preparation of non-clinical parts of various regulatory documents
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Document review, due diligence and gap analysis of existing non-clinical development programs and data packages
SPECIFIC EXPERTISE
New and biosimilar proteins, transgenics
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Therapeutic and diagnostic monoclonal antibodies
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Radio-Immuno-Therapeutics (RIT)
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Peptides, peptidomimetics
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Vaccines: preventive and therapeutic
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Cell therapy, allo- and xeno-transplantation,
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Blood products including hemoglobin therapeutics
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Immediate & prolonged release formulations
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New chemical entities
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Medical devices
POST-MARKETING SUPPORT
Ensuring regulatory sustainability of the marketed products
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Addressing post-authorization commitments by designing Phase IV study protocols, registries, long-term safety studies and interacting with EU Rapporteurs
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Translating MAA/BLA/NDA into marketing documents by preparing publications of key registration studies and presenting data at international conferences and meetings
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Providing continued regulatory compliance through line extensions, variations and new indications
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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