MLC, LLC Consultant
Groton, MA 01450 Phone: 978.448.0953Email: kelsey@mccormicklifescience.com
What We Do > Services
Bridging the gap between discovery and market with efficient execution of the approval process.
MLC, LLC partners with clients to provide compliant, high-quality and cost-effective pharmaceutical, biotechnology and medical device integrated product development services. We offer flexible arrangements to fit your specific needs including onsite and/or offsite services. From small engagements to large contract/consulting projects, we specialize in providing expert services in the following areas:
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REGULATORY AFFAIRS
- CMC, Nonclinical and Clinical RA program support (operational and strategy)
- Regulatory submission management (writing, review, coordination)
- Submission compilation and publishing (paper and/or eCTD)
NONCLINICAL
- Nonclinical medical writing (study protocols, reports, conference materials, publications etc.)
- Developing, planning nonclinical in vitro and in vivo studies
- Data analysis, compilation and presentation
- Expert Pathology services (peer review pathology etc.)
CLINICAL**
- Clinical medical writing (protocols, amendments, study reports, case report forms, investigator brochures, SOPs, informed consents etc.)
- Program Management/Trial Management
- Monitoring
- Clinical Safety: Adverse events reporting and Medical Monitoring
- Data Management
**Satellite location on the West Coast (Newbury Park, CA) with a Phase I/IIa Clinical Research Unit and a Central Imaging Service
QUALITY ASSURANCE/GXP COMPLIANCE
- GMP, GLP and GCP Audits
- Equipment and Process validation
- Analytical Development
- Process Development
- GMP operations
- Technology transfers
- Design of GMP and GLP labs
TRAINING
- CTD (ICH Compliant—Modules 1-5); eCTD
- GMP/GLP/GCP
- Additional customized trainings per request
LITERATURE SEARCHES
- Medical, medicolegal, and scientific data research, retrieval and analysis
- Literature, patent, trademark searches
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* MLC, LLC also has additional capabilities through affiliations with industry Partners including (but not limited to), Discovery Bioanalytical services (GLP/Non-GLP), electronic submission outsourcing services, eCTD software/equipment set-up/validation, GAP analysis, GMP analytical services, Phase I-IIa Clinical Research Unit, radiology imaging services etc. (SEE "PARTNERS" PAGE)
Interested in collaborating with us or have questions?
Please send us a message
"We have worked with McCormick LifeScience Consultants, LLC for the last year and have found this relationship to be extremely beneficial and cost-effective. Kelsey and her consultants are both highly expert and collegial. We have used their services in implementing both our Quality Assurance and Sales programs at Biotrofix. With McCormick LifeScience Consultants wide-range of services, efficient processes, and personal touch, we expect to continue this relationship long-term."
Seth F., M.D.,
CEO of Preclinical CRO
