Proven guidance and implementation!
Biologic products include, Allergenics, Blood & Blood Products, Cellular & Gene Therapy Products, Tissue & Tissue Products, Vaccines, Xenotransplantation, and Fecal Microbiota Products. Elexes offers the following end-to-end solutions for companies developing such products.
- Regulatory
- Quality
- Clinical
- Product
What we offer
Regulatory
Companies partner with us to seek approval and meet the extensive requirements in the Code of Federal Regulations (CFR) and other applicable regulations
- Investigational New Drug (IND) or Device Exemption (IDE)
- Biologics License Applications (BLA)
- 510(k) Pre-Market Notification
- Pre-Market Approval (PMA)
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Orphan Drug Designation (ODD)
- Building or refining Regulatory Strategy
Quality
A robust quality system goes a long way in producing safe and effective products. We assist in developing integrated quality systems per applicable requirements.
- ISO 9001 certification
- GxP (GMP, GCP, & GLP) compliance
- Internal & Supplier audit/ report
- Current Good Tissue Practice compliance
- Clinical quality compliance audits, including pharmacovigilance (PV) audits
- Standard operating procedure (SOP) development for clinical testing
- Project Management
- Interfacing with regulatory authorities
Product
We help you identify and consolidate all the product documents needed for getting a regulatory approval based on the target country’s specific requirements.
- Product development plans
- Tissue facility registration
- Animal testing
- In-vitro testing
- Product specific testing
- Product labeling
- Advertising and promotional material review
- Product due diligence to identify route to market
Clinical
To conduct a clinical trial you need numerous documentation and clinical trial applications to be filed with a regulatory body. We can support you with:
- Clinical gap analyses
- Clinical due diligence assessments
- Clinical trial consulting, design and protocol development
- Trial master file creation and maintenance support
- Project Management
- Clinical regulatory expertise for products in all stages
- Clinical Trial Operations SOPs
- GCP compliance
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