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 Akkeriakkeri
[ /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