Our Consultants

The right combination of skills and experience

At Complya, we realize your biggest concern when considering a consultant is to find someone with the right tools to suit your needs. That's precisely why we maintain such a long roster of consultants with different levels of skill and experience. Our goal is to match you with someone who'll be able to step in immediately and effectively.

Additionally, when an extra set of hands are needed with routine Document Control operations, our consultants can jump in to help out.

 

Jonathan Morse, Principal Consultant and Founder of Complya has a S.B. degree in Chemistry from MIT and over fifteen years of QA experience. Today, Jonathan’s primary role is to match our team of 15+ consultants with our expanding network of Biopharmaceutical and Medical Device clients.

Complya offers the following types of consultants:

Senior Quality Assurance Consultants

  • Senior Quality Assurance Consultants generally possess 25-plus years of industry experience and have held VP- or Director-level Quality Assurance positions. Senior Quality Assurance Consultants provide a broad range of services for Complya's clients:
  • Providing high-level initial gap audits and assessments, and creating strategies to develop or overhaul entire QA systems
  • Assisting with preparation for onsite FDA application inspection
  • Interfacing with regulatory agencies on behalf of clients, and responding to inspection observations or other agency correspondence
  • Establishing product recall strategies
  • Performing GXP audits of contract manufacturers and critical vendors

Quality Assurance Consultants

  • Complya's Quality Assurance Consultants assist with a broad range of "hands-on" GXP services. Most Quality Assurance Consultants have held industry QA positions at the Director or Sr. Manager level. Our Quality Assurance Consultants are senior enough to provide high-level input and are skilled at executing these types of plans hands-on:
  • SOP Generation
  • Batch Record and Validation Review
  • Investigation and Root Cause Analysis
  • Material Review Board Participation and Support
  • Vendor & Supplier GXP Audits
  • CMO Oversight & Person-in-Plant Support
  • Personnel Training & cGMP Training
  • Internal Audits
  • Quality Metrics
  • Stability Program Management & Trending

Senior Regulatory Affairs Consultants

  • Senior Regulatory Affairs Consultants typically possess 25+ years of industry experience and have previously held VP- or Director-level Regulatory Affairs positions. Senior Regulatory Affairs Consultants provide a broad range of services for Complya's clients:
  • Interfacing with regulatory agencies on behalf of clients
  • Developing Domestic and Global Regulatory Strategies
  • Preparing Regulatory Filings
  • Providing regulatory review of submissions and critical documentation

Regulatory Affairs Consultants

  • Complya's Regulatory Affairs Consultants roll up their sleeves to assist with broad services at all levels, including:
  • Assisting clients with day-to-day Regulatory Operations, CMC, and Clinical support
  • Assessing Change Controls and reportable events
  • Reviewing labeling and advertising/promotional materials
  • Preparing regulatory filings
  • Assisting with eCTD format issues

Project Managers

  • Complya's PMP Project Management Professionals support clients in several areas, including clinical trials, commercial manufacturing change controls, regulatory filing preparation, and overall program management.

Document Control Consultants

  • Complya's Document Control Consultants assist clients with EDMS roll-outs, internal assessments, and day-to-day Document Control operations and help develop strategies that encompass the following considerations:
  • Location
  • Filing
  • Retrieval
  • Security
  • Disaster Recovery
  • Retention Period
  • Archiving
  • Distribution
  • Workflow
  • Creation
  • Authentication