Leverage our team's deep scientific and regulatory expertise for impactful medical, regulatory, and QMS writing solutions

Synergy of Operational Excellence and Flawless Writing 

Our lead writer possesses a combined M. Pharm, PhD in Pharmacology, and comes with over 20 years of industry experience. This would help you in ensuring a comprehensive understanding of both the scientific intricacies and ever-evolving regulatory landscape. 

We bridge the gap between scientific comprehension and regulatory compliance. Our team's unique combination of operational, quality assurance (QA), and scientific writing expertise translates into efficient, compliant, and impactful documents. 

We Provide the writing solutions in the following sub-domains

• Medical Writing: Clinical trial protocols, investigator brochures (IBs), study plans (eg., iPSP) and meticulously crafted clinical/non-clinical summaries tailored for applications like 505(b)(2). 

• Regulatory Writing: Systematically address inspectional observations, craft clear and concise technical write-ups, deliver well-researched and persuasive responses to regulatory queries, and support the development of comprehensive study reports, bioanalytical and statistical reports that enable faster approvals.

• QMS Writing Support: We support developing robust QMS covering quality manual, control policies, establish clear organizational expectations with risk and process-based approaches, Prepare Business Continuity Plans (BCPs) and Disaster Recovery Plans (DRPs) to ensure preparedness for disruptions. We support you in the design and development of Standard Operating Procedures (SOPs), efficient data collection and recordkeeping tools (forms, formats, flowcharts), and manage quality metrics for continual improvement. 

Benefits

• Expedited Approvals: Our in-depth understanding of regulatory requirements maximizes your chances of first-time submission success, helping you significantly reduce queries and clarifications

• Mitigated Risk: Our proactive approach to risk identification and mitigation strategies within QMS documents safeguards your research and development efforts, promoting patient safety and regulatory compliance.

• Enhanced Operational Efficiency: Streamline your processes with our team's operational knowledge. We create clear, concise, and user-friendly documents that minimize errors and expedite workflows.

• Scientifically Sound and Impactful Communication: Deliver compelling scientific narratives and impactful writing that strengthens your research and application persuasiveness, ensuring effective communication with regulatory bodies.