It often takes several months to search and hire for an open position and in that time, often other members of the department are overwhelmed with the additional workload. As a consultant specializing in auditing, training and regulatory compliance for small companies, I have had experience with a wide variety of products and services.
Please, do not hesitate to call MSceppa Consulting for a no-obligation discussion.
The objective of MSceppa Consulting would be to assist companies during an interim period when staffing is low and then to assist any new personnel for future projects. Whether you have an extensive project or simply a one-time compliance “need,” MSceppa Consulting can help you.
Compliance Activities include:
Clinical Study Audits
Internal File Audits
GCP Testing Facilities
cGMP - Introduction and advanced
GCP - Clinical Study Compliance
Other Compliance activities include:
Clinical Documentation Review (protocols, Investigator Brochures)
SOP Writing CMC Review
Batch Record Review