Regulatory & Scientific Writing

Kinapse is recognized for providing cost-effective regulatory and scientific writing and document quality control (QC) services to global pharmaceutical, biotechnology and medical device companies.

Our expert writers are trained on ICH GCP and have extensive clinical experience. They work in cross-functional teams, integrating seamlessly with client teams, and building strong, long lasting relationships. We have several engagements running for over 7 years, and one with a Top 5 pharmaceutical company that has been running for over 10 years.

Our team of medical writers, subject matter experts, QC reviewers, publication writers and medical information specialists is located across India, the EU, and US.

What we do
Regulatory Writing
Publications and Medical Information 
  • Clinical study protocols and amendments
  • Clinical study reports
  • Safety narratives
  • Investigator’s brochures
  • Informed consent forms
  • Clinical summary documents
  • Clinical overviews and other regulatory documents
  • Manuscripts
  • Abstracts and posters
  • Slide decks
  • Evidence based response documents
“I would not hesitate to recommend Kinapse to colleagues, and they would be my first choice for any future projects requiring exceptional medical writing skills”
Director Medical Writing Operations, USA
System and Workflow Management

In addition to our core offerings, we also provide administrative System and Workflow Management support to our clients. With this service we support client’s business processes for example through request management, user-administration and reporting. Our experience in this area can be applied to processing requests received through mailboxes for many business processes, including those related to Learning Management Systems (LMS) and Clinical Trial Management Systems (CTMS).

Key benefits to our partners – We bring together the successful elements of a robust partnership to deliver a top quality service to our clients:

 

  • Efficient operations. From daily business activities to efficient project management, we tailor our services to individual clients and the regions in which they operate. We bring efficiency through a focus on continuous improvement

  • Successful track record of high quality With extensive experience in authoring regulatory documents across therapeutic areas and development phases, our writers consistently focus on high quality, on-time delivery. Our quality output is driven through partnering medical writers withmedical writing specialists

  • Proactive and flexible writing team. We can accommodate ad hoc requests, fluctuations in work volume or expedited time frames, while ensuring quality and timely communication with our client teams

“The interaction with the team has been excellent, they are very committed, easy to work with, proactive, and provide high quality deliverables”
Director Medical Writing, USA
“It has been and continues to be a successful partnership. One that is characterized by good communication, transparency, and the willingness on Kinapse part to be flexible to our changing business needs”
Head of Medical Writing, USA

Standalone QC Services

Kinapse provides expert Standalone Quality Control services and commits to quality.

The number of clinical trials and the amount of regulatory documentation required for each trial is increasing. With this increasing workload, sponsors often struggle to complete documents on time to the required level of quality. “Right first time” quality should be a prerequisite, but consistently achieving this is becoming ever more challenging. This is further exacerbated when contractors or vendors outside of the direct control of the sponsor write documents. Poor quality documents pose a risk to patient safety, cause delays in regulatory review and result in wasted effort and budget.

For 8 years, Kinapse has been providing to a very high standard standalone QC services to top pharmaceutical companies. Our team of QC specialists have QC reviewed over 3600 documents, often within very tight timelines.

“We are extremely pleased at the quality of work despite very aggressive timelines. Your team’s ability to respond accordingly by putting multiple reviewers on a document is appreciated as an added value in using the Kinapse team”
Head of Medical Writing, USA
“Thank you and your colleagues at Kinapse for the excellent work on the 2.7.x modules. I really appreciate it given the big volume of the document and the often not so straight forward referral to the source of information and the tight time line”
Medical Writing Lead, Germany

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It is in the clinical space that we do some of our best work and we are proud of the strength, depth and capability of our team to deliver successful clinical advancements.
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Clinical Trial Disclosure

You will be working with one of the most experienced Clinical disclosure teams in the industry, from statisticians to project managers with hundreds of years of combined experience under our belt.