At The FDA Group, in addition to traditional project-based medical writing support, we offer a flexible and efficient solution to your medical writing needs through our Full-Time Consultant (FTC) or staff augmentation model.
Our staff augmentation model allows you to navigate the complex landscape of life science documentation with agility and expertise. Whether you're facing a submission deadline, managing a spike in clinical study reports, or needing specialized writing for a new product area, our approach provides the right resources at the right time.
Our model provides numerous advantages:
Fast Access to Specialized Expertise
Access writers with niche clinical, regulatory, or scientific writing skills as needed.
Scalable Resources
Rapidly expand your writing capacity for time-sensitive projects like NDAs or CSRs.
Respect Your Budget
Engage high-level expertise without the overhead of permanent hires.
Quality and Consistency
Maintain high standards across all documents crucial for submissions and communications.
Flexible Duration
Align writer engagement with project timelines, from short-term tasks to extended programs.
Knowledge Transfer
Benefit from industry best practices and innovative approaches.
Rapid Deployment
Meet tight deadlines with quick access to experienced writers.
Clinical Study Reports (CSR) (ICH E3 compliant)
Protocol Synopsis and full Protocol and Protocol Amendment development
Clinical Evaluation Report (CER)
Clinical Development Plan
Protocol and Protocol Amendment Review
Investigator’s Brochure (IB) and IB Updates
Clinical Trial Protocol (CTP)
Clinical Evaluation Plan (CEP)
Navigating the complex landscape of regulatory requirements is crucial for the successful approval and maintenance of pharmaceutical and medical device products. The FDA Group’s regulatory document services offer comprehensive support from pre-IND submissions to post-marketing commitments.
Our consultants are adept at preparing detailed and compliant regulatory documents that meet the stringent standards of global health authorities, including the FDA and EMA. By partnering with us, you ensure that your submissions are precise, timely, and aligned with regulatory expectations.
Investigational Medicinal Product Dossier (IMPD)
Periodic Benefit-risk Evaluation Report (PBRER)
Effective scientific communication is vital for conveying complex information to diverse audiences, including regulatory bodies, healthcare professionals, and the scientific community. The FDA Group’s medical writers excel in crafting high-quality, clear, compelling, and scientifically accurate scientific communications. Whether you need manuscripts, abstracts, posters, or literature reviews, our team works closely with you to ensure your scientific messages are impactful and professionally presented.
Our services in this area include, but are not limited to:
Scientific Posters
Ensuring the safety of your products throughout their lifecycle is paramount. The FDA Group offers comprehensive safety and pharmacovigilance document services, providing detailed and compliant reports that support the ongoing monitoring and evaluation of your products. Our consultants have extensive experience in preparing essential documents such as DSURs, PSURs, and patient safety narratives, helping you maintain regulatory compliance and uphold the highest standards of patient safety.
Our services in this area include, but are not limited to:
Expert Reports on Preclinical Studies
The development and approval of medical devices require specialized documentation that addresses unique regulatory requirements. The FDA Group’s medical writing services for device-specific documents ensure that all necessary reports and submissions are meticulously prepared.
Our team is experienced in creating clinical evaluation reports, IDE documents, and performance evaluation plans, helping you navigate the regulatory pathway for your medical devices efficiently and effectively.
Our services in this area include, but are not limited to:
Successful medical writing projects require effective project management and consultation to ensure timely and high-quality deliverables. The FDA Group offers expert project management and consultation services, coordinating all aspects of document development from planning to final submission.
Our consultants provide strategic guidance, risk assessment, and stakeholder management, ensuring your projects are completed on schedule and to the highest standards.
Our services in this area include, but are not limited to:
We understand that life science companies often require medical writing expertise beyond the core services outlined above. While these represent our primary medical writing offerings, our capabilities extend much further. If you need specialized medical writing support in areas not explicitly detailed here, we encourage you to reach out.
Our experienced team of medical writers and subject matter experts is ready to understand your unique documentation needs and provide tailored solutions across the full spectrum of medical and scientific communication.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.
