DRUG REGULATORY WRITING

Regulatory medical writing has become more complex with the introduction of new requirements to secure drug approval. We have an integrated knowledge of the directives, regulations, policies and guidelines. We find the most meaningful and practical solutions in accomplishing your objectives of regulatory compliance.

Hostrin Life Sciences staff has extensive medical writing experience including pre-clinical and clinical ctudy reports, IND’s, fast track applications, new drug molecules and clinical summaries for safety and efficacy, ACTD, CTD and eCTD submission format.

Hostrin Life Sciences offering  the following services:

Preparation and submission of Regulatory documentation including:

• PSUR (Periodic Safety Update Reports)
• PV or PhV (Pharmacovigilance Study Report)
• BA/BE ( Bioavailability /Bioequivalence) Studies Reports.
• CSR (Clinical Study Reports)
• Preclinical reports
• QMS (Quality Managements System)
• Expert Reports
• Regulatory/Quality GAP Analysis.
• Package Inserts / summary of product characteristic (SmPC)
• Labeling Protocols SOP’s
• Risk Management (ISO 14971)
• Regulatory submissions (IND, NDA, DCGI Files, COPP Data & Fixed dose combination etc.)