Lachman Consultants Services & Solutions
A Commitment to You From Our President Fran Zipp
REMOTE SERVICES FROM LACHMAN.
Lachman Consultants is supporting our clients with the same expertise, knowledge, and partnership you experienced before “social distancing” became the most spoke phrase in the English Language. All our people, capabilities, and resources are fully engaged when our clients need them most; that time is now.
YOUR NEEDS ARE OUR MISSION.
Many companies are experiencing a shortage of key people. The health of some are directly impacted by the virus, and unanticipated issues may have challenged the ability of some companies to operate in an efficient and effective manner. We recognize your continued commitment to quality and compliance and we are working hard to support all of our clients as their organizations work to achieve their mission in these trying times.
SERVING YOU. SERVING PEOPLE. SERVING THE WORLD.
Lachman SMEs are poised to serve the world’s pharmaceutical, biotechnology and medical device manufacturers, as you help the world recover from COVID-19. Lachman salutes all of you, as well as everyone in the healthcare field, who are working tirelessly to bring the current crisis to an end.
ALL OF OUR SERVICES. ALL OF THE TIME.
We have been working with clients onsite and remotely for many, many years. And today, it is more important than ever to collaborate in new and innovative ways. Lachman Consultants is fully staffed and prepared to help you remotely now and into the future.
Current Remote Service Offerings Include:
- Quality Systems Implementation and Remediation
- Policy, Standard, SOP writing
- Due Diligence Assessments
- Application (ANDA, NDA, 510K, DMF, etc.) review and assembly
- CAPA plan reviews
- Investigation reviews and writing
- Batch record reviews for product disposition
- Audits (Internal and Supplier) done virtually through technology
- Facility Design Reviews
- Data Integrity Reviews – Lab and Manufacturing
- Cross contamination assessments
- Environmental monitoring assessments
- Environmental monitoring excursion assessments
- Annual GMP Training and certification
- FDA Meeting Preparation
- 483 and Warning Letter Responses
- Supplier Quality Management
- Quality Agreements
- Management Controls implementation
- Device Design History Files
- Analytical Method Review
- Strategies for conducting manufacturing activities with only essential personnel
- Design of Quality Organization for sustainable compliance
Thank you for your continued trust in us for the past 40+ years.
If you require immediate assistance or have any questions regarding the services we can provide in support of your business during these trying times, please fill out and submit the information requested below: