Support for Medical Product Launch and Commercialization
Medical product launch and commercialization is the process of bringing a new medical product, such as a drug, medical device, or diagnostic test, to the market and making it available to patients. This process involves several stages, including research and development, clinical trials, regulatory approval, manufacturing, marketing, and distribution.
The launch and commercialization process is complex and highly regulated, and it requires the involvement of multiple stakeholders, including pharmaceutical and biotechnology companies, regulatory agencies, healthcare providers, payers, and patients.
To successfully launch and commercialize a medical product, companies need to have a comprehensive understanding of the market landscape, patient needs, and regulatory requirements. They also need to have a solid commercialization strategy that takes into account pricing, reimbursement, and market access considerations.
We partner with pharma, biotech and medtech companies to navigate this complex process more efficiently and effectively. Our highly experienced team can offer high-quality services around regulatory support, clinical trial management, market access support, commercialization strategy, and post-marketing support, which can help to streamline the product development and commercialization process.
We help pharmaceutical, biotech and medical device companies to bring their products to market more efficiently and effectively by providing the following services:
- Regulatory support for product registration and obtaining marketing licenses
- Product Launch & Commercialization related Medical Writing
- Medical Information Call Center to support HCPs, Caregivers and Patients
- Strategic advisory for gaining market access and patient reimbursement
- Post-marketing Safety Management for the launched product
- Medical education and patient support
Our Medical Writing Services
At Techsol, our expert team of Medical writers have an extensive research background, scientific knowledge, and ample experience to develop scientfic content requried for product launch, commercialization and post-marketing support.
Following are the key focus areas where our medical writing team has the expertise to deliver high-quality services throughout the drug / device development lifecycle as per applicable regulatory guidelines:
Medical Affairs & Commercial
- Abstracts, Manuscripts & Posters
- Marketing & Brand Content Development
- Medical Information Content Authoring
- Standard Response Documents
- Prescribing Information & Package Inserts
- Therapeutic Content Presentations
- Conference Poster Presentations
- Journal and Conference Submissions
- Medical marketing Reviews and Reports
Non-Clinical Writing
- Non-Clinical Summaries Preparation
- Non-Clinical Overview Report
- Permitted Daily Exposure (PDE) Reports
- CTD Module IV Non-Clinical Report
MedTech Writing
- Scientific Literature Review Reports
- Clinical Investigation Plan
- CER Writing (Clinical Evaluation Report)
- PER Writing (Performance Evaluation Report)
- PMCF Plan (Post Marketing Clinical Follow up)
- PMCF Study Summary Report
- Manuscript Writing and Publications Support
- Biocompatibility Reports Writing
- Toxicology Reports Writing
- CMC / Analyte Report Writing
Safety Report Writing
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit-risk Evaluation Reports (PBRERs)
- US FDA Periodic Safety Line Listings
- Risk Management Plans (RMPs)
- Development Safety Update Reports (DSURs)
- Local Safety Summaries (LSSs)
- Safety Signal & Risk Analysis Reports
Service FAQs
There are two types of service models that your company can choose from:
Medical Writing FSP Model: Our team will take the responsibility of managing all medical writing activities for a complete clinical program or for an individual study with a cost-effective pricing structure.
Dedicated Resoucing Model: We can have specialized resources allocated for your organization to hand-hold all types of medical writing needs for a fixed duration.
We use the best of technology platforms that helps us to deliver our medical writing services through continous real-time collaboration with sponsors. Following are some of the systems we use:
Compier Medical Writing Platform: This is our proprietary 100% digital content management platform that facilitates rapid content authoring, completing real-time collaborative review and allows continous content lifecycle management. specifically for rapidly processing soft such as Microsoft Word to create documents.
Reference management software: Our Medical writers use reference management software such as EndNote, Mendeley, or Zotero to manage and organize their references.
Content management systems: If sponsors want us to use content management systems (CMS) like Veeva Vault, Documentum or Sharepoint, our team is familar with how to store and manage documents, track versions, and facilitate collaboration between different team members.
Typesetting software: Medical writers use typesetting software such as LaTeX or InDesign to create well-formatted documents, such as scientific publications and regulatory documents.
Medical Terminology software: Medical writers use medical terminology software such as SNOMED, ICD-10, or MedDRA to ensure accurate and consistent use of medical terms.
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.
