Are your documents ready for regulatory submission for your IND or NDA? 

Your drug development program has overcome many challenges and required a substantial investment to get to this point.  Now your Investigational New Drug Applications (IND) and New Drug Applications (NDA) submissions need writing expertise to manage the transition from pre-clinical trials to clinical development, through regulatory submission and approval to post-marketing

Inform and accelerate your therapies with a writing partnership supported by Certara’s leading technology and flexible, highly-qualified professionals.  Reduce risk and alleviate internal burden with writers who have in-depth expertise and experience to efficiently drive the document development process throughout the entire drug development life cycle.

We have the largest consultancy of experienced regulatory and medical writers in the industry. Over 250 writers, including 100+ PhDs and MDs, in 17 global locations.

We collaborate closely with our partners to achieve their goals.  What our customers say:

“The medical writer was excellent in working with the team on the protocols. She was very responsive and met the needs of the team.”  – Clinical Trial Head at leading global pharmaceutical company in Korea

“The writers are very knowledgeable and responsive. A great company! It lives up to its reputation.” – Regulatory affairs manager

“Synchrogenix is very competent in providing technical writing services.” – Associate director at publicly traded, global pharmaceutical company

Regulatory writing to expedite your submissions

Accelerate your time to submission with seasoned regulatory writers who coordinate across submission documents to maximize successful creation and delivery for your product.

Our team is highly skilled in managing the transition from pre-clinical to clinical trials and development, including Chemistry Manufacturing and Controls (CMC), through submission and approval, and on to post-marketing safety writing

Our writers are fully conversant in industry guidelines such as those issued by the International Council of Harmonisation (ICH) and the International Committee of Medical Journal Editors (ICMJE), while adapting to your specific preferences and procedures.

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Expert scientific and medical writing

Increase exposure and impact of your key findings and accelerate your therapy to healthcare providers and the scientific community with the knowledgeable professionals your scientific investment deserves.

We have experience in over 75 indications in fifteen therapeutic areas, including medical devices, diagnostics, and rare diseases.

  • Maximize the probability of acceptance decisions with our outstanding writing support and process guidance
  • Mitigate your risk of potential misrepresentations by working effectively across geographies and cultures to gain alignment across authoring teams
  • Alleviate your internal burden by owning and driving project timelines
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Medical publications and publications planning

Strategic development plans and execution for communication of data across the full product development life cycle from discovery through commercialization.

Over the past year, we have supported client manuscripts across a variety of therapeutics areas including immunology, neuroscience, oncology, and rare disease that were published in journals including Journal of Drugs in Dermatology, Clinical Rheumatology, Current Medical Research and Opinion, and Journal of Pharmacology and Experimental Therapeutics.

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Linda Tabas Associate Director, Publications and Publications Planning

Linda has over 30 years of experience in scientific communications and publishing.  Prior to joining Certara, she was a scientific communications consultant at Eli Lilly, overseeing medical publications supported by TPOs.

Ann Benesh, MPH Principal Writer

Ann has over 20 years of experience in medical writing.  Before joining Certara in 2013, she was a senior medical writer at Amgen for over 7 years and previous to that, a medical writer at 3M Pharmaceuticals.

Maria Lopez Director, Nonclinical/CMC Regulatory Writing

Maria has been at Certara for over 23 years, starting out in regulatory writing and quality assurance and advancing to her current role where she heads up the nonclinical/CMC regulatory writing team.