Our Specialized Medical and Scientific Writing Services to Support your Regulatory and Clinical Development Needs
Medical Writing plays a pivotal role to define the path of medical research and clinical development. The art of synthesizing information from past research outcomes and developing new scientific knowledge for a medicinal product requires a talented multi-disciplinary team with access to a wide-range of scientific literature databases.
At Techsol, our expert team of Medical writers have an extensive research background, scientific knowledge, and ample experience in clinical development to generate clear and concise manuscripts, publications, and clinical trial protocols across various therapeutic areas.
Services We Offer
Our team has been helping several pharma companies for regulatory writing, performing the quality review, conducting a technical review of dossiers, and identifying gaps in already compiled documents. Our Clinical and Non- clinical writing services are delivered as per the regulatory compliance requirements mandated by regional Health Authorities (HAs) of North America, the EU, Australia, and New Zealand.
Clinical Writing Services
- Protocol synopsis for Phases I to IV studies
- Study Protocols for Phases I to IV studies
- Investigator Brochure
- Study reference manuals
- Informed consent documents (ICD)
- Patient information sheet (PIS)
- Clinical Study Reports (CSRs)
- CER Writing
- CSR Synopses for public disclosure
- Patient Safety Narratives
Non-Clinical Writing Services
- M-2.4 Non-Clinical overviews
- M-2.5 Clinical overviews
- M-2.6 Non-Clinical summaries
- Non-Clinical Reports writing
- PDE Reports/Toxicology Reports
- Summaries and overviews for EU and US
With increasing regulatory complexity across global markets, company expansions with mergers and acquisitions, Chemistry, Manufacturing, and Controls (CMC) organizations are overwhelmed with complex operational challenges. With our highly capable team members, we can help in optimizing your organization’s operations, and fulfill various medical writing needs.
- CMC regulatory strategy, critical review and assessment, related to the content of the DS (Synthetic or semi-synthetic small molecule, natural product, peptide) and DP (tablet, capsule, patch, cream, wafer, solution, injectable) Quality Modules (Module 2: QOS and Module 3: Quality) of the Common Technical Document (CTD) for regulatory submission
- CMC content authoring for IND, CTA, IMPD, DMF, NDA, ANDA, MAA
- CMC Regulatory Gap Analysis for Identification, Assessment and Provision of CMC Regulatory Mitigation Strategies for Remediation
- Authoring of Annual Report, Drug Master Files, Dossier Amendments and Supplements
- Preparation, Publishing and submission of Electronic Common Technical Document (eCTD) applications
Medical and Scientific communications play an important role to bridge the gap between pharma companies and their customers. It is highly important that unbiased and accurate medical information is shared to HCPs, Care Givers and Patients at the right time for a given medicinal product or medical device.
With our qualified team of skilled and experienced medical writing professionals, we can deliver the following types of medical and scientific content tailored to your business needs.
- Marketing Materials
- Medical Editing
- Scientific Editing
- Product and Package Labels
- Conference materials (abstracts, poster presentations and slide sets)
- Journal/conference submission
- Medical marketing reviews and reports
- Literature reviews