Our purpose is to accelerate
your progress in the life sciences.
Meet with a member of our team to find the right solutions for your life sciences company.
Talk to Us
Flexible resourcing
Your needs are variable—sometimes you need a full-time medical writer, while other times you need flexible support. Whether you’re looking for on-demand short- or long-term support with individuals or teams, we can help.
Consultative approach
We have depth of experience supporting clients to clarify goals, capabilities, timing, and gaps to present you with custom-crafted solutions. We leverage your internal team or outsourced providers and fill any gaps you may have.
Here’s how we help.
Writers & communicators
Our consultants are experts at writing and analysis, content editing, and quality control (QC), as well as coordinating and finalizing content for internal approval and submissions.
Regulatory submission teams
We provide cross-capability submission teams of all sizes across therapeutic areas with skilled leadership oversight. We have a creative approach to meeting or exceeding accelerated timelines.
Medical writing build-out capabilities
We provide you with support to build out your internal capabilities to meet current and future needs.
A sample of our writing and communications expertise.
Regulatory
writing
- Clinical regulatory writers
- CMC regulatory writers
- CSR appendices preparation/TMF support
- Documentation coordinators
- Nonclinical regulatory writers
- Pre-submission publishers
- QA auditors
- QC specialists
Scientific
communications
- Grant writer
- HEOR/RWE writer
- Med Comm specialists, leads
- Medical Education specialists, leads
- Publications writer/planner
Document
types
- Advisory committee packages
- Briefing packages
- Clinical and nonclinical protocols, CSRs, IBs, D/PSURs, all
- Clinical Evidence Reports
- Clinical, nonclinical, CMC CTD reports and summary documents
- Dossiers
- Grant proposals
- Medical education materials
- Presentations
- Safety narratives
Capabilities
- Functional infrastructure build
- Gap analysis/needs assessment
- MW job descriptions and career ladders
- Publication planning
- QC checklists
- SOPs, templates, processes
- Style guides
- Submission strategic planning and oversight
How to build great regulatory submission teams.
Want to learn more about our services?
Our purpose is to accelerate
Insights
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![Medical Writing Spring Roundtables by AMWA New England]()
News & Events
Medical Writing Spring Roundtables by AMWA New England
The New England Chapter will hold its annual Sunday brunch on April 14th at the Hilton Garden Inn in Waltham, MA. This popular event will feature a leisurely late breakfast followed by lively roundtable discussions led by knowledgeable AMWA members who will share their insights, offer valuable advice, and answer questions.
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![Thoughtfully Using Technology to Accelerate Drug Development]()
Industry Insights
Thoughtfully Using Technology to Accelerate Drug Development
By Jenny Thayer, BioBridges’ Medical, Regulatory, and Scientific Communications SME While an open-minded approach to onboarding new technology is essential to advancing drug and device development, a thoughtless approach can cause additional stress, challenges, and ultimately resistance to technologies over time. Following, I explore how thoughtlessly incorporating technology can cause additional headaches, and ways […]
