Medical Writing and Regulatory Submissions
Experts in authoring, compiling and submitting clinical and regulatory submissions on a global basis
Medical Writing and Regulatory Submissions
Experts in authoring, compiling and submitting clinical and regulatory submissions on a global basis
Decades of regulatory and medical writing experience
At G&L, we have a wealth of experience supporting the successful delivery of clinical and regulatory documents.
Our seasoned team specializes in authoring the clinical components of regulatory submissions such as, MAAs, BLAs/NDAs, CTAs, and INDs.
With meticulous attention to detail and a deep understanding of regulatory requirements, we ensure that your documents are clear, compelling, and fully compliant.
Partner with us to streamline the submission process and bring your therapies one step closer to market.
Services include:
- Protocol and IB authoring
- INDs, CTAs, briefing books, MAAs/NDAs/BLAs, etc. - authoring and submission
- Specific therapeutic area expertise
