Expertise, Experience, Excellence

Akkeri is a boutique nonclinical drug development consulting firm providing strategic scientific advice and operational support to the pharmaceutical/biotechnology industry.

Contact Akkeri

akkeri

[ /ˈãkːeri/ ] anchor, noun (Icelandic, from Old Norse)

What We Do

  • Provide strategic and scientific advice by expert consultants
  • Develop nonclinical program plans to support clinical/CMC/regulatory strategy
  • Design, implementation, and oversight of nonclinical studies (pharmacology, ADME, toxicology)
  • Study monitoring and CRO qualification
  • Review/write nonclinical study reports to ensure accuracy, quality, and scientific rigor
  • Provide integrated interpretation of data and risk analysis/mitigation
  • Authoring regulatory documents to include: IND/CTA, NDA/BLA/MAA, Investigator Brochure (IB)
  • Document preparation and meeting participation in support of global Regulatory Authority interactions
  • Author position papers, targeted data summaries, product labeling
  • Due diligence and gap analysis

Areas of Expertise

Scientific Strategy

  • Experience with various therapeutic modalities
    • Small molecules
    • Biologics
    • Cell and Gene Therapy
    • Vaccines
  • Experience in most therapeutic areas and all stages of development
  • Experience with common and specialized routes of administration
    • Including: oral, IV, SC, dermal, ocular, inhalation, and direct CNS administration
  • Pharmacology, ADME, Toxicology study expertise - with individual specialization in
    • DART (Developmental and Reproductive Toxicology) and Juvenile Toxicology
    • Safety Pharmacology (CV, Respiratory, CNS)
    • Abuse Liability
  • Product Quality Assessments
    • Impurities, leachables, excipients
  • In silico ICH M7 genetic toxicology assessments
    • Leadscope
    • N-nitrosamine CPCA

Regulatory Services

  • Regulatory advice on nonclinical strategy
  • Representation for Regulatory Authority interactions for nonclinical topics
  • Expertise to ensure adequacy of study reports for submission:
    • GLP and ICH compliance
    • SEND implementation
  • Regulatory authoring
    • All nonclinical components required to support regulatory submissions
    • All writing done by technical experts
    • All documents 100% QC’d
  • Project management available for additional program support, to include tracking of study report and submission document timelines

Scientific Services

  • Independent nonclinical program management and operational support
  • Study design and CRO selection
    • Long standing interactions with most CROs
    • Current knowledge of individual CRO capabilities
  • Placement and management of contracted studies
  • CRO qualification site visits
  • Nonclinical study monitoring
    • GLP compliance
    • Scientific integrity
    • Technical performance
    • Monitoring reports provided
  • Review and ensure quality of final reports
  • Literature searches and data compilation