Regulatory Services
Our Scientific writing professionals are provided as an incorporated part of our clinical development expertise or as a standalone provider with every method tailored to deal with consumer needs. We create clinical documents of excessive standard/quality, performs peer review and quality checks, and achieves the project management of various Regulatory, clinical writing activities in both Electronic Common Technical Document (eCTD) and CTD modules.
Our services involve writing of inclusive range of medical scientific documents, compilation, quality check, technical review of dossiers and performing gap analysis for already prepared dossiers adhering to stringent timelines and high-quality parameters.
Regulatory writing services (Clinical):
• Clinical study report preparation and review (eCTD Module 5)
• Clinical overviews (eCTD Module 2.5) including literature review and references
• Clinical summaries (eCTD Module 2.7) including clinical pharmacology, efficacy, and safety
• Biowaiver support and providing justification document services
• Clinical justification documents
• Providing clinical and nonclinical document support
• Handling queries during HA meetings and responding to them
• Technical review of dossiers and gap analysis in clinical part
• Strategic support for study design
• Protocol writing
• Expert review of phase I, phase II, phase III & phase IV clinical studies including protocol amendments
• Patient Support Program
• Preparation of labelling justification document/CCDS
• Regulatory CSR writing
• Aggregate Report Writing: Periodic Safety Update Report (PSUR), Periodic Benefit-Risk Evaluation Report (PBRER) and Periodic Adverse Drug Experiences Report (PADER)
• Investigator Brochure (IB) development and expert review
• Informed Consent Form (ICF) preparation and expert review
• Clinical trial summary for EudraCT
• Preparation of IND application supporting documents
• Clinical sections of New Drug Applications (NDAs), Investigational New Drug Applications (INDAs), Abbreviated New Drug Applications (ANDAs), New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS)
• Regulatory dossier writing services (Clinical part)
• Preparation and review of clinical overview (module 2.5) and clinical summary/summaries (module 2.7)
• Regulatory support for compilation and review of pre-submission package
Non-clinical writing
• The pre-clinical drug development approach plays a dynamic character in the procedure of medicine expansion. We contribute support for non-clinical safety studies and regulatory non-clinical writing through group of extremely skilled expert by providing high quality on-time document delivery to our clients.
• Pre-IND Supporting Documents
• Investigator’s Brochure (IB)
• Pharmacological Written Summary
• Pharmacological Tabular Summary
• Toxicological Written Summary
• Non-clinical part of IND package (electronic Common Technical Document [eCTD] module 2.4 and 2.6)
• Preparation and review of Non-clinical Summary/Summaries (Module 2.6)
• Preparation and review of Non-clinical Overview (Module 2.4)
• Preparation and review of Non-clinical Study Report
• Preparation and review of Non-clinical Protocol
• Toxicological Tabular Summary
Permitted daily Exposure analysis (PDE)
