EXPERIENCE. EXCELLENCE.
BIOLOGICS
Lachman Consultants has a reputation for demonstrated excellence in technical, regulatory consultation, and guidance services for biologics, including cell and gene therapy, human cell and tissue products, monoclonal antibodies, biosimilars and many more.
Our trusted team of experts have a wealth of knowledge and the foresight to keep pace with the continually changing world of the biologic life sciences, while closely monitoring the ever-changing landscape of new regulations.
SCHEDULE A CONSULTATION MEET LEADERSHIP TEAM
Best in Class Consultation & Advisory Services for Biologics & BioTech
- CDER, CBER, and CDRH
Regulated Product support,
including:- Monoclonal Antibodies
- Growth Factors
- Replacement Enzyme Therapies
- Peptides
- In-vitro Diagnostics
- Cellular and Tissue-based Therapies
- PAI Audit Prep
- Regulatory Transitions of
- HCT/Ps to Drug Products
- Manufacturing Technology Transfers
- Regulatory Submission and Preparation
- Testing Assessment and Guidance
- CGMP Facility Audits
- Regulatory Inspection Preparation
- Due Diligence Assessments
ADVANCE CONFIDENTLY
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