Services

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:
 
  • Continuous monitoring of regulatory requirements and adapting the plan to reduce development time and ensure optimal presentation of submission to regulatory authorities.
 
  • Providing customized, strategic response to meet our clients’ goals. Our “learning/confirming” 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
 
  • 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 product’s lifespan – from discovery through to the post-authorization phase

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