Mir Mohammad Shahroz

Execution of regulatory strategies against overall portfolio development and Life-cycle management strategy, Risk assessments and recommendations for various regulatory scenarios, Training, mentoring and building a strong team, Coordinates and leads identification of new business opportunities, strategic and operational analysis of opportunities, constructing and leading deal teams, contract negotiation including post-deal alliance management, Perform QMS/GMP audit, Presentation over the technical/Business issue in international platform

Preparation of dossier template and SOP of dossier preparation for various markets, Regulatory submission Dossiers (NCE/Generic/Herbal/Neutraceuticals/Cosmetics) as per regulatory requirements (GCC/SFDA/MENA/African Market/ASEAN/ South Africa/CIS etc), Assessment of dossier for product submission and perform the GAP analysis, Variation handling (Assessment and filing) for different countries, Handling/Trouble shooting-eCTD (Lorenz-Docubridge)

Preparation and Review of the pertaining documents (Example: Development report, specification, testing method, analytical method and sterilization validation protocol and report, batch analysis, DMF, Bioequivalence protocol and report etc.) of eCTD filing in US/Europe, Preparation and Review of Dossier for US, Europe Market, GCC, ASEAN, Latin America, CIS countries, Response of deficiencies received from respective agency, Facilitate the GMP inspection

Interaction with the Client, Evaluation of Client’s Dossier, Preparation and Review of Client’s Dossier, Preparation of CTD file as per GCC/SFDA requirements, Preparation of Deficiencies/Variation file, File Submission with SFDA/GCC, Training deliver to department colleague, Riyadh, Saudi Arabia, Clients: GSK, Pfizer, Apotex-Canada, Genepharma, Torrent pharmaceutical Limited, Jamjoom Pharma

eCTD and CTD preparation for USFDA/European Agencies, Preparation of Deficiencies response, Preparation and Review of Open part of DMF, Preparation and Review of Drug development report, Analytical validation documents, Sterile Validation documents, Batch manufacturing records, Batch packaging records, Specifications, Analytical test procedure, stability data, protocol for Bioequivalence study, BA and BE study report, Bioanalytical method validation protocol and report

CTD preparation for European Agencies/USFDA/Canada, Review of Drug development report, Analytical validation documents, Sterile Validation documents, Batch manufacturing records, Batch packaging records, Specifications, Analytical test procedure, stability data, protocol for Bioequivalence study, BA and BE study report, Bioanalytical method validation protocol and report

eCTD and CTD preparation for USFDA, Preparation of Deficiencies response, Annual reports, CBE 0, CBE 30, PAS, Review of Open part of DMF, Review of Drug development report, Analytical validation documents, Sterile Validation documents, Batch manufacturing records, Batch packaging records, Specifications, Analytical test procedure, stability data, protocol for Bioequivalence study, BA and BE study report, Bioanalytical method validation protocol and report, Regulatory Compliance: Facility Audits & Responses (US FDA), Facility Compliance Audits: Stability data, BMR, BPR, Method transfer report, Sterility Assurance, Sterilization Processes, Validations

Drug substance and drug product analysis (Dissolution, Assay, Related substances) of Different Formulation, Stability samples, In-process samples by HPLC, UV, Calibration of Equipment (HPLC, Weighing Balance etc.), Maintain the GLP