Our Services
Regulatory and Clinical Writing Services
01
Biological License Application
Assisting with the preparation and submission process of biological license applications for product approval.
02
Briefing Book
Creating comprehensive briefing books to support regulatory submissions and meetings with health authorities.
03
Clinical Study Documentation
Providing essential documentation for clinical studies to ensure regulatory compliance.
04
Clinical Evaluation Report
Preparing clinical evaluation reports that assess the safety and effectiveness of drugs, biologics, and medical devices.
05
Clinical Investigation Plan
Developing clinical investigation plans that guide the design and conduct of clinical trials.
06
Clinical Study Protocol
Crafting detailed clinical study protocols - outlining the design, methodology, and objectives of trials.
07
Clinical Study Report
Crafting clinical study reports that clearly summarize results and conclusions from clinical trials.
08
Committee Charter
Developing committee charters that define the structure, responsibilities, and governance of clinical trial committees.
09
Common Technical Document
Assisting with the preparation of the Common Technical Documents (CTD) to support marketing approvals.
10
Informed Consent Form
Creating informed consent forms to ensure participants fully understand the risks and benefits of clinical trials.
11
Investigator’s Brochure
Preparing investigator’s brochures that provide key information about investigational products for clinical trials.
12
Investigational Medicinal Product Dossier
Assisting with the compilation of investigational medicinal product dossiers for submission to regulatory authorities.
13
Investigational New Drug:
Assisting with the preparation of investigational new drug applications to initiate clinical trials with new drugs.
14
Narratives
Writing clinical study narratives that summarize individual patient experiences and outcomes during clinical trials.
15
New Drug Application
Preparing new drug applications (NDA) for submission to the FDA for approval of new pharmaceutical products.
16
Nonclinical Study Report
Generating nonclinical study reports summarizing preclinical safety and efficacy data for regulatory submission.
17
Orphan Drug Designation Application
Assisting with orphan drug designation applications to secure regulatory incentives for treatments targeting rare diseases.
18
Pediatric Investigation Plan
Creating pediatric investigation plans that outline the development of medicines for children, in line with regulatory requirements.
19
Pediatric Study Plan
Developing pediatric study plans that support the approval of medicines for pediatric populations.
20
Periodic Safety Report
Compiling periodic safety reports to provide updates on the safety profile of clinical trial products.
21
Premarket Approval Application
Assisting with the preparation and submission of premarket approval applications for new medical devices.
22
Premarket Notification 510(k)
Helping with the preparation of premarket notification 510(k) submissions to demonstrate that a new medical device is substantially equivalent to an existing one.
23
Product Information
Providing accurate product information for regulatory submissions, marketing, and labeling compliance.
24
Recombinant DNA Advisory Committee Application
Assisting with the submission of applications to the Recombinant DNA Advisory Committee for gene therapy and genetic research.
25
Regenerative Medicine Advanced Therapy Designation Application
Supporting the preparation of applications for regenerative medicine advanced therapy (RMAT) designation to expedite the development of regenerative treatments.
26
Regulatory Response
Providing expert regulatory responses to queries or deficiencies raised by regulatory authorities during product development.
27
Statistical Analysis Plan
Developing statistical analysis plans that define the methods and procedures for analyzing clinical trial data.
28
United States Prescribing Information
Assisting with the drafting and updating of U.S. prescribing information to ensure regulatory compliance and clarity for healthcare providers.
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