Consulting

Personal service. Comprehensive expertise.

With Caligor Coghlan Pharma Services as your partner, you can trust that the right pathways and processes are in place and that our experts have the passion to deliver what you need and more.

Clinical Supply Services

Have one of our experienced Clinical Supply Managers dedicated to managing your supply chain. Whether you are resource constrained or do not want to invest in a full-time employee to manage your project, our Clinical Supply Manager will operate within the processes and procedures of your company, completing all necessary tasks and providing documentation. Tasks include:

  • Working with Clinical, Data Management and Quality groups to develop study design
  • Budgeting
  • Comparator drug and ancillary sourcing
  • Clinical Supply IRT design and User Acceptance Testing
  • Label text generation including Regulatory review, translation and approvals
  • Supply chain management including batch production planning and inventory management
  • Packaging and labeling
  • Logistics planning
  • Returns, destruction and study close out

Pre-Approval Access Programs / Expanded Access Programs (EAP)

Our knowledgeable leadership team has decades of combined pre-approval access experience specifically in the strategic design and implementation of global EAPs. We are here to assist you during the planning stage of the program through close out. Our experts take into account all cross-functional and stakeholder needs to ensure that a comprehensive project plan is developed and implemented which meets both your short and long term objectives.

Global Regulatory Solutions

Being certain in today’s global medical market is difficult. At Caligor Coghlan Pharma Services, we believe that companies encounter enough challenges with getting their products developed; regulatory questions and concerns should not be one of them.

Regulatory Affairs is a dynamic and multicultural discipline. If you are going global, it is essential to have someone with global experience.

Our expertise in the global regulatory markets ensures our clients make informed choices and hold realistic expectations from concept to commercialization and from submission through to approval and life cycle management. Rather than telling you what you cannot do… Caligor Coghlan Pharma Services Global Regulatory will help you achieve what you want to do… worldwide!

At Caligor Coghlan Pharma Services, we understand the pressures that govern product development activities, from concept to commercialization. Having a solid regulatory partner can help alleviate some of these pressures and allow you to focus on your critical internal needs.

This is achieved by offering clients services which they can choose from as their needs require, including:

KEEP EMPTY

Lisa was appointed Chief Executive Officer of Caligor Coghlan Pharma Services on June 25, 2018, and she also serves on the Caligor Coghlan Pharma Services’ Board of Directors. She is responsible for leading the growth of Caligor Coghlan Pharma Services’ Clinical Supply Services and Global Pre- Approval Access Services.

Strategic Product Development Support

We understand that not all companies developing products are doing so with the intention of marketing the products themselves. You may be focused more on the initial R&D and early development phase. Regardless of where you envision your finish-line, we understand all aspects of product development and can assist by mapping out a regulatory strategy that provides maximum value for your product either upon marketing approval or via out-licensing prior to marketing approval.

 We provide customized regulatory solutions such as:

  • Label negotiations
  • Advisory committee preparation
  • Key opinion leader selection
  • Market analysis and forecast
  • Competitive intelligence
Strategic Regulatory Consulting
Caligor Coghlan Pharma Services Global Regulatory solutions will provide application of the necessary regulatory knowledge and experience combined with an understanding of business and industry practices to support and enhance the complete product development cycle from R&D and proof of concept through post-approval marketing. Including such areas as:

  • Evaluation of Product Portfolio
  • Clinical Development Support
  • Strategic Product Development
  • Full market Application development and submissions in all regions
    • Biologics
    • Drug
    • Device
    • Combination
  • Extended Access Program
    • Post-Approval Support
  • Scientific and Medical Communications
  • Product Life-cycle Support