Experience excellence in technical, regulatory consultation and guidance services for combination products.
Lachman Consultants offers a wide range of consulting services for areas that include medical products, SaMD, materials and components, processes and mechanical engineering and manufacturing, as well as testing and validation. Our team of experts provides consultative services for combination products such as auto-injectors, pre-filled syringes, patch delivery systems and many others.
Lachman Consultants supports clients with compliance guidance that includes due diligence review, general auditing, quality assessment remediation work for 483 or Warning Letters, as well as design history file building and documentation. We offer a full menu of regulatory services that includes traditional 510k, de novo filing under 510k and Pre-Market Approvals.
Lachman Consultants Combination Products Services and Features:
- Harmonization of Drug/Biologic – Device Development
- Due Diligence Assessments
- Quality Systems Audit to 21 CFR Part 4
- Quality Assessment Remediation Work for 483 or Warning Letters
- Design History File Remediation
- 510k Submissions
- Assistance on NDA/BLA submissions
- Pre-Market Approval (PMA)
- Validation Review
- Preparation for Application
- FDA-Related Services
- Developing and Enhancing Laboratory Controls
- Optimizing Product Formulation and Processes
- Assessing Product Stability