Through a dedicated single point of contact, multi-disciplinary groups of accomplished FDA and industry experts are assembled from our Compliance, Regulatory, and Science and Technology Practice Groups.
Our comprehensive teams are selected and assigned based on each client’s unique set of objectives, needs and circumstances.
Our expertise and knowledge, gained through decades of experience, is evident throughout our extensive quality systems, protocols and procedures. Lachman Consultants is especially well versed to serve the needs of companies with biological products that are regulated as drugs transitioning from 505 or 505b2, serving clients requiring reporting, documentation, requirement changes and requirements for post-approval changes.
In addition, other areas of Lachman Consultants’ service expertise include:
- Auto-Immune Diseases
- Replacement Enzyme Therapies
- Invitro-Biologic Devices
- Many Others
With a legacy of expertise and demonstrated success in these areas and many others, Lachman provides a full suite of Biologics consultation services, including GNP audits as well as Pre-IND and Pre-BLA FDA meetings and required documentation.
Featured in Lachman’s range of services for Biologics, Biosimilars and Biotechnology are:
- Small and Large Molecule
- GNP Audits
- Regulated Transitions of Tissues and Sub Therapies
- Manufacturing Technology Transfers
- FDA Pre-Meetings
- FDA Documentation
- Testing Assessment and Guidance