Services

REGULATORY AFFAIRS, STRATEGIC PLANNING AND PRODUCT DEVELOPMENT

STRATEGY AND INNOVATION

A strategic plan typically includes a competitive review of the therapeutic area, including risks analysis and choices available in the full clinical development program leading to product registration.

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 and filing of submissions

  • Preparation of MAA, BLA or NDA
  • Clinical Trial Applications (CTAs/IND) and related documents (IMPD, IB,etc).

Regulatory affairs, Interaction with health authorities worldwide

  • 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.

TECHNICAL DEVELOPMENT

Technical Development

  • Manufacturing process definition and gap analysis. *Pre- and post-process characterization and 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

GMP readiness and Manufacturing

Ensuring robust, compliant and timely supply of clinical material

 

  • Clinical material 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

We offer a full-range of integrated clinical development services for medicinal products

  • 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

Preparation of non-clinical development plans including detailed outlines of the most efficient program for initiation of a Phase I study and ultimately for submission of a MAA/BLA

  • 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

 

New & “biosimilar” recombinant proteins, including transgenic

  • 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

Ensuring regulatory sustainability of the marketed products

  • 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