PHarmaceutical and biotechnology
Apium Health provides pharma and biotech clients with product development support, with a specific focus on nonclinical program development and management. We have experience in extensive therapeutic modalities such asnovel small molecules (or 505b2 programs), peptides, monoclonal antibodies, vaccines, oncolytic viruses, and cell/gene therapy for indications including, but not limited to, oncology, cardiovascular disease, neurological disorders, neurodegeneration, pain, anti-infective, antibiotics, and endocrine disorders. We work with clients on the following aspects of new product development:
- Design, implementation, and critical evaluation of preclinical IND-enabling programs;
- Monitor and supervise toxicology studies for scientific integrity and compliance;
- Preparation of regulatory submissions (INTERACT, pre-IND, IND, NDA);
- Addressing technical questions from or facilitating meetings with regulatory authorities
- Critically evaluating feedback from Agency meetings and interactions;
- Preparation of drug development strategies, gap analyses, program planning, and program management;
- Due diligence reviews of scientific and regulatory dossiers for in-licensing or financing activities;
- Performance of GLP audits of preclinical studies and CROs.