When working on your drug development projects, you will need to perform a thorough analysis of the information and resources needed to complete all required tasks. It is highly unlikely that all required regulatory and general drug development knowledge, information and skills can be found in-house and therefore you will probably need to use consultant(s).
You may use them for various tasks: providing in-depth regulatory intelligence reports, support or lead your Marketing Authorization procedures, prepare and manage Scientific Advice procedures, write or review your Standard Operating Procedures (SOPs), manage regulatory aspects of your clinical trials, etc.
Good Regulatory Affairs (RA) consultants can give you outside perspectives, unbiased analyses, and specialized support in virtually all areas of your drug and medical device development process.
Here is a handy “cheat sheet” that can help you find the right Regulatory Consultancy for your projects and business:
Great Regulatory Consultancies are able to adapt to new projects, environments, cultures and team structures quickly. They understand the unique regulatory constraints and challenges of your projects.
It is extremely important that you can trust the person you are working with. Do you know someone who has already worked with your potential RA Consultancy? Ask them for their feedback. Transparency and great track record are usually a good starting point when looking for regulatory support.
Building professional relationships is critical for project success, and when done effectively, RA Consultants should become your trusted advisors. This is extremely important in projects where communication with Regulatory authorities is required and can influence the success of the project. Lack of professionalism is a huge red flag.
Be clear about the type of consultancy you need, the potential duration of the services and the scope of work.
Be careful in simply choosing the lowest cost consultant. Consider the value of the consultant’s work to your project.
Instead of reinventing the wheel, bring in someone who has dealt with your particular regulatory affairs concerns many times before. You’ll see a massive return on investment when you get the right consultant to address your current situation.
Great RA Consultancies are approached for their expertise in the industry. With a thorough understanding on the regulatory field, they are able to provide guidance on best practices and enable the client to accomplish the desired goals. It is their job to bring the latest knowledge and skills to the table so you don’t need to worry about certain aspects of your projects.
Ideal RA Consultancies will work together with your team, are dependable, have a strong willingness to learn, and are receptive to feedback. They are not afraid to challenge ideas, but do so productively and with respect.
Prior to making any recommendation, good RA professionals will listen carefully and try to understand the customer needs, before they propose a strategy, new idea or a solution.
Good RA Consultancy has a confidence to navigate complex conversations in the workplace, as well as manage cross-cultural communication effectively, in order to increase the chance of business success.
Your challenges during the drug development require unique solutions that satisfy your requirements and are specifically tailored to support your regulatory strategy. Be wary of RA consultants who are only verbatim citing available regulations without further interpretation and analysis tailored to your product.
Good RA Consultancies will meet their daily, weekly and monthly goals set by their clients while respecting the allocated time and resources. They will meet their deadlines. For example, with good RA Consultancies you will get clearly outlined timelines of a regulatory task to be done, pro/con analysis of all interdependent activities, strategic considerations impacting timelines, immediate notification when timelines or project might be in danger, creative solutions in difficult situations, etc.
As experienced advisors, your RA Consultants should be able to quickly see “the big picture”, the position of your product in the regulatory landscape and necessary steps to reach your business goals faster. Carefully selected and executed RA strategy could save you months and sometimes even years of time.
Using RA Consultancies can significantly improve the quality of your decisions and thus the viability and profitability of your project or business.
If you need any support from experienced RA Consultants, don’t hesitate to contact us at firstname.lastname@example.org