Consulting and services in pharmaceutical industry with regulatory affairs, R&D&I, Clinical trials worldwide. Professor in University:- Prepares and reviews the dossiê for regulatory submissions- Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management- Understanding of medical terminology, statistical concepts, and guidelines written medical by AMA Style Guide- Knowledge of the guidelines of ICH- Clinical research with medicine and medical devices- Registry the study clinical in ethics committees, clinical trials- Preparation of dossier for drug, medical devices registration - Elaboration of post-registration processes that make up the annual history of the product;- Regularization of companies;- Regulatory strategies for problem-solving according to global legislation Anvisa and ICH member countries;- Elaboration of standard procedures, manuals, and guides;- Analysis of technical documents such as DMF, analytical validation report, stability, across gap analysis- Submission of processes to regulatory agencies such as ANVISA, ANMAT, EMA, FDA, HEALTH CANADA, etc- Preparation of leaflets- Expertise in researching, compiling, and analyzing clinical and scientific evidence quickly, training the team, professor - Researches, writes, and edits clinical and regulatory documents by applying functional expertise and clinical drug development knowledge. Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other documents- Elaboration of a scientific and technical rationale to respond to the requirements of the regulatory agency- Technical expertise and background in the use of medical writing templates (e.g., review, documentation-based platforms, etc.);- Analyse the news projects about due diligence, viability and impact the registry news products, PDCA strategics- Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements;- Elaboration of folder's temples, emails, pipeline, portfolio, and animations for advertising- List of pharmaceutical and biotech companies for your network, advertising, and growth.For know more details, let's go talk with me.🤝