Regulatory Writing

Technical and scientific brilliance leads humanity. Regulatory affairs shows that geniuses also care.

You are responsible for keeping a product on the internal or global market that literally saves and maintains lives. In the midst of ever-changing market conditions, you must secure the turnover you need in order to continue to develop these safe and effective products. Moreover, you need to respond to changing regulatory requirements in order to keep your products on the market. You have your eyes on the global markets and the strategic direction that a company should take – you need someone to put that vision on paper. Whether CTDs, 501(k)s or NDAs, SmPCs, ICFs or CSRs… You need someone who understands the clinical ramifications on one hand and the strict and extensive regulatory requirements on the other. Rely on a medical doctor with clinical experience who has spent over a decade translating every conceivable type of document for global Big Pharma companies.

Obviously, more established companies already have entire regulatory affairs departments, and moreover, many companies work with independent regulatory affairs experts with many years of industry experience. These more established freelance regulatory affairs professionals may also be interested in increasing their productivity and output through collaborative partnerships. Reach out for more information on how digital document management and quality assurance techniques, as well as natural language processing, may be of benefit to you.

Testimonials

Freelance language service vendors like Sarai offer exclusive and highly customised services to a small group of carefully selected customers. However, Sarai has worked with many agencies over the preceding decade that she can recommend to meet any Life Science translation needs. Contact Sarai for a referral if required.

Specific benefits of our collaboration with Sarai have included her subject matter expertise, translation quality and responsiveness

We are greatly impressed by her high responsibility and accurate translations, especially for health care documents.

Sarai's speed, accuracy, quality, subject matter expertise and responsiveness have really impressed us.

We genuinely miss Sarai when she is unavailable - she is an asset to our global regulatory affairs team!