About Us

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About Us

Coatbe is providing high quality medical writing and clinical trial disclosure services to global pharmaceutical, biotechnology and medical device companies. Medical writing plays crucial role in success of clinical trial, well written medical and regulatory documents not only help to achieve compliance but also saves time.

We are a thriving organization that cares deeply about meeting the goals of every client with due regards to compliance and quality. We are a people and customer focused organization comprising of highly experienced professionals working together to serve our clients.

Our clients include pharmaceutical & biotech companies with products in early and late-stage clinical trials. We build our service teams around our clients' needs with multiple engagement models.

Our experienced

Clinical Writing professionals are committed to working with you—in accordance with US/EU/ICH guidelines and regulations—to deliver a wide range of high-quality medical writing on time and in required style/format. We understand the importance of communicating the details concisely and accurately, so our documentation is crisp and to the point.

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Our Team

Our team is comprised of medical writers, subject matter experts, QC reviewers and clinicians. Our team consisting of individuals with qualifications in Medical, Pharmaceutical and other Life Science subjects (MBBS, MD, BDS, PhD and Masters in pharmaceuticals or life sciences and PhD) has expertise across therapeutic areas.

Our team understand the complexities of writing in a highly regulated environment and has comprehensive understanding of various Regulatory guidelines such as ICH-GCP, FDA, EMA and local as applicable.

Coatbe provides writing support services throughout the Drug Development Lifecycle.

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your success results from our proven
clinical writing structure and philosophy

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Diversity

Clinical Writing team members have diverse educational and professional backgrounds, with qualifications in medicine, pharmacy, nursing or life sciences and previous experience in pre-clinical research, clinical laboratory, study coordination, regulatory affairs, and data management.

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Flexibility

Our document preparation process involves experts from Regulatory, Statistics and Medical Affairs who are readily accessible for review and feedback and proactively provide solutions.

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Communication

As we draft various regulatory documents, we are in close contact with our other cross-functional areas. We also maintain strong communication with our clients to ensure that the first draft is consistent with their expectations.

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Quality

We have internal quality control system at each developmental step to ensure accuracy and consistency. Additionally, senior management plays an active role throughout the delivery process.

Each member of our core regulatory writing team draws on extensive industry knowledge and therapeutic expertise to effectively meet our clients’ product development requirements and provide top-notch medical writing services. Each writer is a post-graduate-level life science scholar. They enhance their scientific and technical expertise through continuous and concurrent medical education and study-specific training. Our team is trained to expertly prepare regulatory documents in accordance with ICH Guidelines and suitable for submission to regulatory authorities, including FDA and EMA.