I have experience in medical publication writing like research papers writing , systematic review writing , Meta analysis writing , literature...
Consult top freelance regulatory medical writers with expertise in clinical regulatory writing, regulatory writing services, and more. Kolabtree is the world's largest platform for hiring trusted freelance scientists and consultants.
We take several measures to help you work with full confidence and peace of mind.
Keep your project private
Restrict who can see your project and send you proposals. Invite only specific freelancers to view your project.
NDAs and IP protection
Our T&C include a default confidentiality clause that protects your IP. Sign NDAs for added protection before disclosing project details.
Kolabtree ensures safety and security of your payments and personal information and project details. Kolabtree’s T&C includes a default confidentiality clause. You can also sign NDAs and custom agreements with freelancers for additional protection.
Post your project and receive quotes from relevant freelancers. You can also search for specific freelancers by expertise and invite them to your project. Discuss your project details with each freelancer before picking the one best expert.
We assure you of a 100% satisfaction guarantee, which means you only pay when you’re 100% satisfied with the work delivered. If you aren’t happy, we will refund 100% of your money.
You can choose to pay either a fixed or an hourly fee based on your scope of work. If you’re not sure how much your project costs, you can discuss with freelancers before arriving at a mutually agreed fee.
Kolabtree's terms and conditions prohibit freelancers from claiming ownership of intellectual property, and as a client, you are able to reinforce the message with additional communication, agreements or contracts.
Kolabtree is the place to go for professional help. Work was done promptly and efficiently. I would definitely seek the service again in my future projects
Maher AnousIndependent Plastic Surgeon, USA
A broad network of skilled people in many fields that is very hard to find elsewhere.
Roger SkagerwallTech entrepreneur, Sweden
The quality and quantity of accessible experts on Kolabtree is priceless.
Webster WatnikProfessor at California State University, USA
Contact experts directly
Speak directly with freelancers and explain your requirements.
100% satisfaction guaranteed
Pay only once work is delivered and you’re happy with it.
No upfront fees
No minimum commitment or contract required.
Flexible, secure payments
Pay a fixed or hourly fee. We hold your funds in escrow until you’re ready to pay.
Post project (Free)
Post your project publicly for all freelancers to view and send you proposals, or interact with specific freelancers privately.
Choose the best expert
Get bids from relevant experts. Interact freely with them before making a hire.
Share files, make audio/video calls and collaborate with your chosen expert.
Verify the project is complete to your satisfaction before paying the expert.
New drugs and medical devices need to navigate the complex maze of clinical trials and regulatory approval before they can go to market. In the process, a myriad regulatory documents need to be drawn up. With increasing numbers of drugs and medical devices being submitted for approval, there is a growing demand for regulatory documents that are compliant, scientifically sound, and well-written. Regulatory writing has, therefore, become a recognized niche within the pharmaceutical and medical device industries.
Regulatory writers work with regulatory agencies and various medical, technical, and operations professionals to draw up and review documents related to the different phases of clinical trials and market authorization. These documents need to adhere to the guidelines for Good Clinical Practice (GCP) according to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and they need to conform to the requirements of the relevant regulatory agencies (e.g., FDA, EMA) and institutional review boards (IRBs).
The various documents that regulatory writers work on include:
- Clinical study applications (CTAs)
- Common technical documents (CTDs)
- Investigational new drug applications (INDAs) and investigational medicinal product dossiers (IMPDs)
- Clinical trial study reports (CSRs)
- Marketing authorization applications (MAAs)
- Integrated summaries of efficacy and safety
- Periodic safety update reports (PSURs)
- Informed consent forms
- Risk management plans (RMPs)
- Pediatric investigation plans
- Proposed pediatric study requests
- Pediatric use marketing authorizations (PUMAs)
- New drug applications (NDAs)
- Post-marketing documentation
- Investigators’ brochures
- Applications for orphan drug designations
- Requests for product-specific waivers
- Drafting response documents to address issues raised by regulatory agencies
- Clinical evaluation reports (CERs)
- Labeling regulatory documents (Summary of Product Characteristics, SmPC)
Experts in regulatory writing will typically be medical writers with several years of experience writing for a contract research organization (CRO) or pharmaceutical company. They usually have a PharmD, MD, or a Master’s or Ph.D. degree in an allied scientific field. They will have extensive knowledge of the regulatory requirements relevant to their region (e.g., FDA or EMA), as well as the ICH guidelines.
Regulatory writers work either as freelance medical writers or regulatory affairs consultants or for CROs, medical device or pharmaceutical companies, medical writing agencies, regulatory and governmental agencies, and regulatory affairs consultancies. The job titles of regulatory writing experts vary and can include Medical Writer, Regulatory Writer, Regulatory Submission Writer, Associate Medical Writer, Senior Regulatory Affairs Medical Writing Associate, and Senior Medical Writer. While some may be generalists, others may specialize in e.g., biologics or medical device regulatory writing.
To hire a freelance regulatory medical writer, the fee generally ranges from 40−100 USD per hour depending on the required skillset and the level of experience necessary.
The hourly fee can be negotiated upfront based on the estimated number of project hours, or a flat fee (for projects of a defined scope) can be discussed. If you need short-term/temporary access to these specialists, then hiring a freelance regulatory writer or regulatory affairs consultant on our platform is a convenient and cost-effective way to harness their expertise.
The best way to attract the top Kolabtree freelancers in this field is to make your project description informative. You will need to provide information on the following:
- Skills required (e.g., expertise in medical device regulatory writing)
- What the project area is (e.g., development of a biorobotics device)
- What the project entails (e.g., ensuring regulatory compliance with EMA and MDR guidelines)
- What the deliverables are (be specific about what you need the outputs to be)
- Duration of the project (provide an estimate of how many hours work you will need per week/by when you need the project to be completed)
- By when you need to hire (having more leeway on this will give you more time to choose the best expert for your needs)
- Your budget (per hour or fixed fee)
- If you are unsure what exactly is required, providing as much detail as possible will allow the experts to still make an informed bid for your project and suggest the best routes forward.
Our platform makes it easier than ever before to connect and collaborate with regulatory medical writers and other regulatory affairs specialists.