Cedarburg Pharmaceuticals

Project Management

Our centralized approach to project management makes us the right choice for your development project

The process of successfully developing a drug or an API is complex. The science behind a drug or Active Pharmaceutical Ingredient (API) drives the project, while effectively managing the complexities of the project ensures its success. Cedarburg Pharmaceuticals has developed a unique centralized approach to managing your project that will:

  • Provide you with an experienced project manager as your single point of contact that will work with you before, during and after your project to set goals, timelines and budgets. He/she will provide you with frequent updates and be there to answer your questions that you may have along the way.
  • Ensure the most capable and appropriate scientists are assigned to your project based on their education, experience and areas of expertise.
  • Effectively manage all the resources your project needs and make sure they are available whenever they are needed.

What makes Cedarburg Pharmaceuticals the right choice to manage your drug or API development project?

Cedarburg Pharmaceuticals, a division of Albany Molecular Research, Inc. has successfully managed complex drug and API development projects for years. We have refined our approach through experience and adapting to the needs of our customers. The end result is our unique and effective centralized approach to project management. Cedarburg Pharma is the right choice to manage your drug or API development project for a few simple reasons:

  • 3 specialized teams combine their expertise and experience to accomplish your project’s goals within your timeline and budget constraints.
  • Communication. Communication. Communication. It’s that important and we know it. You need to know what’s going on all the time. Our customers tell us consistently how good we are at communicating with them to keep them informed about the progress of their project.
  • Business-focused project management. Most drug development projects are about more than just science. You have investors, a board of directors and other key stakeholders that look at your project as a business opportunity. We will manage your project with those key stakeholders’ needs and requirements in mind.
  • High levels of customer satisfaction. We have a high rate of repeat business with our customers and we are very proud of that. In fact, over 75% of our business comes from repeat customers. They like the results we get for them and the way we manage their projects. We think you will too.

Our Centralized Approach to Project Management

Unlike many contract API development and manufacturing companies, our project management system is centrally managed. This means that all aspects of your project, whether analytical, quality, process development etc. will be organized, managed and coordinated through a single point of contact. This allows every aspect of your project to receive the same high level of attention that it deserves.

At Cedarburg Pharmaceuticals, our centralized approach to managing your project includes experts from three critical disciplines – client services, scientific operations, and resource management. These 3 teams will work very closely together and with you, putting the central focus on your project to ensure its success.

Cedarburg Hauser's Centralized Project Management System

Our client services, scientific operations and resource management teams will provide you with valuable and timely services before, during and after your project to ensure you achieve the scientific outcome you are striving for within you time and budget constraints.

CLIENT SERVICES

Our client services team has one goal – to make sure you are satisfied with the way your project is being managed and executed. Your single point of contact will help ensure everything possible is being done before, during and after your project to ensure we have helped you successfully achieve your scientific goals within the timeframe and budget you have. Before the project begins

  • Facilitate the execution of Non-Disclosure Agreements
  • Provide a timely review of your materials and coordinate the appropriate people to participate in preliminary technical discussions
  • Prepare and submit clear and well thought out proposals and timelines to capture your unique needs
  • Facilitating execution of contracts, initiation of new vendor status and arranging for project kick off meetings

During the project

  • Coordinate weekly or bi-weekly teleconferences to discuss the progress of your project
  • Provide detailed meeting minutes as well as a summary that tracks all action items
  • Provide timely and proactive communication, outside of regularly scheduled meetings, concerning any project-related developments
  • Coordinate and manage requests for information, documents, materials, etc.
  • Be a reliable, accessible single point of contact for any project related question!

After the project is completed

  • Ensure any requests are handled quickly
  • Coordinate the delivery of all final products, required documents and reports

SCIENTIFIC OPERATIONS

Our scientific operations team evaluates every project, makes sure we have the expertise and equipment required, assigns a scientific study director to your project and makes technical recommendations for improving efficiencies and finally managing the scientific aspects of your project from start to finish. Before the project begins

  • Evaluate the scientific feasibility of the project
  • Our scientific operations team carefully evaluates the science behind your project to ensure that we have the expertise, equipment and resources available to accomplish your goals within your time-frame and budget.
  • Ensure the most appropriate scientific expert is assigned to your project
  • We assign a Study Director to your project based on how our scientists’ education, areas of expertise and experience align with the needs of your project. Your Study Director will work along side the Project Manager throughout the duration of the project to provide the required and appropriate scientific expertise, ensuring the technical success of your project. Whether the problem is a difficult, low yielding step in your synthesis, or separating closely eluting impurities in an HPLC method, Cedarburg Pharma’s project managers will coordinate the technical expertise to solve these issues quickly and efficiently.
  • Recommend options for improving efficiencies to save time and money Many of our customers approach us with MedChem or early development routes that need to be optimized to be more realistic, practical and safe for the next phases of development. Our scientists will use their experience and expertise to identify potential opportunities and recommend alternatives that will create the most efficient process for your API to improve your yields, your quality and your timeline.
  • Improve safety and environmental considerations Our scientists have experience identify safer routes, alternative reactions and different reagents or solvents that may make your product safer while also reducing the impact on the environment.

During the project

  • Apply our scientific expertise to your product’s development
  • Coordinate development activities to ensure that the most time is spent on the key / critical aspects of your project
  • Provide technical updates to you and the project team prior to planned team meetings. This document includes a high level summary of the work since the previous meeting, synthesis and analytical results and discussion sections, and objectives for the coming week.
  • Prepare and submit DMFs, CMCs and any regulatory documentation required
  • Our scientists and regulatory experts can help you with filing DMFs in North America and Europe, writing CMC sections of ANDAs and NDAs, and filing regulatory documents with the DEA if it is a requirement of your project.

After the project is completed

  • Provide a detailed technical report
  • Answer any technical questions that may arise

RESOURCE MANAGEMENT

Our resource management team ensures that you have all the scientific resources, equipment and raw materials that will be that will be needed at each stage of your project. Before the project begins

  • Ensure that the appropriate facilities, equipment, materials and personnel are available to meet your project’s specific needs.
  • Identify raw material, reagent and solvent suppliers that meet or exceed your specifications at the best price.

During the project

  • Ensure that the appropriate materials are on hand and that any resource conflicts are handled appropriately throughout the duration of your project.
  • Offer the flexibility to understand that project priorities change, and working with the team to accommodate these needs.

After the project is completed

  • Coordinate all packaging and shipping needs for your project, including final product, samples and appropriate disposition of waste.
  • Schedule resources for future project requirements