Medical Affairs Consulting

Experts in Medical Writing & Clinical Affairs

At GForce Life Sciences, our medical affairs consultants excel in bridging the gap between science and strategy. Our team’s key responsibilities include strategic planning, stakeholder engagement, and regulatory compliance, ensuring that every phase of your product’s lifecycle is optimized for success. These professionals play a pivotal role in crafting impactful medical communications, supporting product launches, and engaging with key opinion leaders to drive your initiatives forward. 

Navigating complex regulatory environments is a cornerstone of our approach. GForce’s medical affairs consultants stay ahead of evolving regulations by leveraging deep expertise and proactive planning. We ensure compliance without compromising innovation, providing tailored solutions that align with both global and local guidelines. 

The skills essential for successful medical writing consultants go beyond technical knowledge. Our consultants bring a unique blend of experience, exceptional communication abilities, analytical thinking, and strategic foresight to the table. With GForce Life Sciences as your partner, you gain access to a team that excels at solving complex challenges, delivering results that position you for long-term success. 

Our Range of Capabilities

GForce Life Sciences offers a comprehensive suite of medical affairs consulting services, designed to meet the diverse needs of pharmaceutical and biotech organizations. From precise medical writing to critical trial management, our team of medical affairs professionals plays a vital role in every phase of drug development and lifecycle management. 

Our capabilities include: 

  • Portfolio and Asset Lifecycle Management: Strategizing to maximize value across a product’s lifecycle. 
  • New Drug Applications (NDAs): Expert guidance to ensure seamless submissions and approvals. 
  • Medical Writing: Producing clear, accurate, and compliant documentation to support clinical and regulatory goals. 
  • Epidemiology and Patient Assessment: Leveraging data-driven insights to inform strategy and improve outcomes. 

Our consultants also excel in clinical staffing and consulting, ensuring that your operations are supported by top talent at every level. By integrating these capabilities, we create seamless workflows that enhance efficiency and support successful outcomes. 

At GForce Life Sciences, we take every necessary step to ensure your goals are achieved, combining deep expertise with a commitment to excellence. Whether navigating the complexities of the drug approval process or managing clinical trials, our clinical affairs consultants are here to guide you every step of the way. 

We Have a Network of Skilled Medical Writers

GForce Life Sciences knows that quality is the most important factor in producing any document. Our highly experienced network of medical writers is committed to providing you with clear and concise documents that are sound from both a scientific and a regulatory perspective. 

GForce’s team has authored countless Clinical Study Reports (CSRs), clinical protocols, Investigator Brochures (IBs) and components of Investigational New Drug (IND) applications. We have extensive experience writing the clinical components of marketing applications, including New Drug Applications (NDAs) and Biologics License Applications (BLAs) in the U.S. and Marketing Authorization Applications (MAAs) in Europe.  

Medical Writing Services

Our team of IND consultants, CSR consultants, and NDA consultants has significant experience authoring a variety of regulatory documents across a wide range of therapeutic areas and all phases of development, including: 

  • Marketing Applications 
  • Integrated Summaries of Efficacy (ISE) and Safety (ISS) for U.S. Submissions 
  • Clinical Components of Common Technical Document (CTD) (Module 2): Clinical Overview (Module 2.5); Summary of Clinical Efficacy (Module 2.7.3); and Summary of Clinical Safety (Module 2.7.4) 
  • Nonclinical and Clinical Pharmacology Summaries and Overviews 
  • CSRs & Clinical Protocols (across all phases of development) 
  • INDs and IND Amendments 
  • Orphan Drug Applications and Annual Reports 
  • Investigator Brochures 
  • Clinical Protocols and Amendments 
  • Safety Narratives 
  • Development Safety Update Reports (DSURs) 
  • IND and NDA Annual Reports 
  • Regulatory Agency Briefing Documents 
  • Advisory Committee Briefing Packages 
  • Pediatric Study Plans (U.S.) 
  • Document Quality Assurance 
  • Regulatory Documents (CMC, Clinical and Nonclinical) 
  • Document Development SOPs 
  • Submission Document Management 

 “I have to tell you, I am impressed with your ability to present new consultants promptly. I haven’t seen anything like it before.”

— Vice President of Clinical Affairs, Global Pharmaceutical Manufacturer

Learn how GForce Life Sciences can help accelerate your growth.

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