You are developing a new pharmaceutical product and think you would benefit from the services of a consultant with expertise in the Chemistry, Manufacturing, and Controls (CMC) requirements of global pharmaceutical regulatory bodies, but you also need to make the most of your CMC budget. Although CMC consultants may seem expensive, in the long run a good consultant will end up saving you time and that is real money.
Consultants can provide you with extra capacity to assist with your submission, but they can do much, much more, for example:
- assist with your product development plan.
- provide a CMC regulatory strategy and pathway.
- identify gaps in your source documentation and development package before you start assembling your FDA meeting package or submission.
- help you find a CDMO for your product.
- provide technical guidance with development of your non-compendial analytics, and especially critically needed potency methods.
- assist with the identification and development of orthogonal methods for characterization of your product.
- furnish process and product development technical guidance.
- serve as “person-in-plant” to observe your drug substance and drug product manufacturing.
- carry out a mock pre-approval inspection (PAI); and
- many other activities which can prevent regulatory obstacles before they happen.
You know that “time is money”. A CMC consultant can ultimately save you money by helping you to avoid mistakes that can cause delays and rework during product development and regulatory review.
To help you hire the best CMC consultant for your project, you should consider the following essential questions: WHAT, WHEN, WHO, HOW, and WHY?
WHAT type of CMC support do you need?
First, identify your goals and your priorities, then honestly evaluate your in-house CMC strengths and weaknesses. CMC consultants can complement or augment your strengths and fill in existing gaps.
In addition to the examples noted above, some of the other specialized services a CMC consultant can provide include providing scientific support when you encounter a development hurdle; assisting with design of your process validation study; helping to define phase-appropriate product characterization testing for your product; preparing your FDA meeting briefing document; assisting with your response to information requests from the FDA; designing a shipping validation study; helping you design and qualify your new manufacturing facility for use; assisting with due diligence audits; responding to FDA Form 483 findings; and a wide variety of other CMC-specific tasks.
Do you have a novel product? A new manufacturing platform? If you need something, just ask! Experienced CMC consultants have likely already encountered situations like yours and can help you address your specific needs.
Most importantly, defining the scope of work up-front will help you identify the best consultant(s) for your project. After discussion with the consultant, you may find that your initial scope of work needs some redefinition, but the work put into the initial definition of the scope will facilitate your consultant search and better inform your needs to the consultant, allowing the first discussion to be much more productive.
WHEN is the best time to engage a CMC consultant?
Ideally you should proactively engage a consultant before your timelines are endangered and your program is in dire need of help! It is easier and quicker in the long run to get it right the first time. This also allows the consultant time to get to know you and your product much better and will unquestionably help you avoid regulatory, developmental, and even pipeline challenges.
Another consideration is that good CMC consultants are often quite busy. A consultant who has already worked with you and is familiar with your program is much more likely to prioritize you over a new client.
In the real world of accelerated timelines and constantly evolving regulatory hurdles, consider hiring a consultant as soon as you suspect you need one.
WHO should you engage?
After identifying the scope of work, it’s time to begin your consultant search. CMC consultants should have years of relevant experience in industry, FDA, USP, and/or other similar organizations. In general, consultants are familiar with many different types of products, situations and potential roadblocks and have “heard it before,” allowing them to help you navigate the expectations of regulatory agencies.
Speak directly with the person(s) or organization(s) you are considering, so you may evaluate the expertise, experience, and the communication skills of potential consultant to ensure they meet your specific needs and are compatible with your organizational culture.
Remember that consultants working 40 hours a week, or more are likely booking clients in advance. If you select your ideal consultant at the last minute, the consultant may have prior commitments which prevent them from taking on your project in the desired timeframe. You may even end up with a delay in your project timelines, so contract your preferred consultant early!
HOW do you make the most of your consulting budget?
Once you’ve selected your consultant and the contracts are signed, determine the best way to communicate with your consultant to ensure both parties have access to everything needed to get the work done efficiently. This helps to maximize your return on the investment.
First, assign a main point of contact within your organization who will be copied on all correspondence between the consultant(s) and your team. This helps ensure the consultant gets the needed information in a timely fashion. Next, consider having a project kickoff meeting to allow all parties to meet (if only virtually) so all parties can gain a strong mutual understanding of the project, the product, the communication pathways, and the timelines. This will lead to more effective communications between team members as the project moves along.
Determine the frequency and duration of regular team meetings (if applicable). Some organizations feel more comfortable having many frequent team meetings to be sure things are on track. Having too few meetings to save money may not keep all team members up to speed on the project, while having too many meetings may waste your team’s valuable time (and your consulting budget). Consider having targeted meetings between selected team members and the consultant for efficient use of your team’s time.
Identify a file sharing service for document exchange to allow for secure file exchange, live editing of documents, and version control. This can be particularly useful when the project team is spread out over multiple time zones. Depending on the consultant you choose, a file sharing service may be provided at no additional cost to you as part of the consulting contract.
Know your source documentation and where it is stored. Having your consultant search through file after file to find information which may or may not exist will give your consultant lots of billable hours, often with little benefit to you.
For large and/or multidisciplinary projects, consider utilizing a Project Manager (PM) to coordinate the efforts of all parties, help keep your project on time, ensure that you receive all agreed-upon deliverables, and track the consulting budget. Clients often do not want to spend “extra” for this support; however, complicated projects involving multiple consultants, in-house staff and/or moving parts generally benefit from a PM to keep the project on time and on budget.
WHY use consultants?
Consultants are a tremendous resource, if used correctly. Consultant regulatory expertise can help ensure that you meet the necessary regulatory guidelines, especially where dynamic gray areas may exist in the interpretation of the guidelines. Consultants will be able to address current regulatory hot topics before they become an issue for you. Consultant technical expertise helps ensure a streamlined product development pathway with a higher probability of success through clinical development, licensure, and post-licensure. The consultant can help you avoid technical issues that could delay or sink an aspiring product.
Experienced CMC consultants will help you with the services you need, and sometimes ones you don’t know you need, while helping you stay on time and on budget. Ultimately, the consultant can be not just an asset but also a good return on your investment.
Written by Kerin Ablashi with contributions by Ron Salerno, Reginald Neal and Chris Bussineau. Many sincere thanks to Ron, Reggie and Chris.