The Situation – Lots of Writing, but Little Training
If you’re in the pharmaceutical or medical device industries – whether a start-up or established global business – you know all too well that to get your products to market your people have to…
Write. And do lots of it... specifically, producing page after page of regulatory submissions for the health authorities, both in the USA and around the globe.
Meeting Packages. New Drug Applications. Biologic License Applications. Responses to Questions. Post Approval Submissions. Annual Product Reviews. To name just a few.
At the same time, your very smart people have been educated as scientists and engineers – but not necessarily as writers. Few have taken a formal technical writing course as undergraduates (and if they did, it had little or no focus regulatory writing). And the PhDs on your team are likely to have received little or no writing advice on their doctoral thesis. And even if you have skilled medical writers, they can struggle trying to decipher the documents your technical people need to produce.
How We Can Help – Workshops, Coaching, Services to Support Your Efforts
For the past decade, Communication Partners has been working with pharma and medical device companies large and small – from firms doing cutting edge work in antibody drug conjugates and CAR-T, to multi-national firms producing small molecules and biologics (and the devices that deliver product).
We have read thousands of pages of regulatory documents. We know – and can teach – the key principles that make even the most complex documents readable. And we know the industry. You can take advantage of any or all of the following services:
Customized Writing Workshops – This one-day training workshop is customized with examples and exercises from your firm. Thousands of industry professionals have taken our workshops to rave reviews. We can create a more general course across a range of regulatory documents or concentrate on one segment – for example, Quality Module 3 in the common technical document or the non-clinical portion of Module 2.
Individual or Group Coaching – Some of the best teaching occurs in a coaching setting – working one-on-one or with small groups on documents in-progress. We can do this individual coaching in conjunction with our workshops or separately. You get the benefit of our deep knowledge of your industry with years of experience in running an academic writing center.
Reviewing, Rewriting, and Editing Documents – Up against a deadline for submitting to the Health Authorities? Need to get a key document to the FDA? Consider engaging us on short notice to improve the clarity and structure of that document.
Revising Templates – Are your templates doing the job? Do they provide both the right guidance yet allow flexibility for writers? We can analyze and revise your templates for maximum efficiency.
Joining Your Team at the Point of Need – We’ve become a key contributor to teams working on a range of documents. We can come on site, or work with your people remotely to ensure that your submission makes a powerful argument to your regulators.
You can count on us to be flexible and adaptable to whatever you need to achieve excellence in your submissions.