Anila Mico Email & Phone Number

Cambridge, Massachusetts, United States

Responsible for providing RA strategy for products under development in orphan indications (primary biliary cholangitis, acute-on-chronic liver failure, cholangiocarcinoma, urea cycle disorder). Responsible for leading health authority meetings and communications. Point of contact for FDA/US Agent for Genfit SA. Responsible for leading IND, CTA, NDA, briefing books, ODD, BTD, FTD, PSP submisions.

Cambridge, Massachusetts, United States

Responsible for all regulatory affairs activities in US and wider North America region.

Watertown, Ma

Responsible for RA strategy and submissions NDA, MAA, IND, PSUR, PAS, CBE30, MAA variations, FDA/EMA meetings briefings...

Watertown, Ma

Responsible for RA strategy and MAA, NDA, IND regulatory eCTD submissions for new broad-spectrum antibiotics developed for the treatment of complicated life-threatening infections including those caused by multi-drug resistant gram negative bacteria.

NDA/ANDA submissions for radiopharmaceutical products, cGMP compliance and FDA inspections, post-marketing drug adverse event reporting, establishment and drug listing, RA department lead.

Define the GRA strategy and prepare regulatory submissions for drug and drug device combination products.

• Prepare NDA, IND and ANDA in CTD and non- CTD format. • Prepare CBE, CMC, DMF, ADE, DDMAC, NDA & ANDA AR, IND Amendments, facility registrations, drug listing, product labels, FDA Meeting Packages. • Represents RA in multifunction project teams, determining regulatory pathway for NDA, IND and ANDA, supplements and other regulatory matters.• Reviews all the documents that go in FDA submission and writes submission sections. • Communicates with FDA Project Mangers on different regulatory issues. • Write and review RA, GMP & QS SOPs • Review Design Plans, Input/Outputs/Verification and Risk Analysis. • Design Verification and Validation Protocols and Reports. • Writes and reviews Drug Stability Protocols and Reports and Sterilization Qualifications and Validations. • Maintenance of Sterility Studies, Biocompatibility Reports, Method Validation Protocols and Reports.• Reviews clinical studies protocols, related documentation and reports.

• Prepare ANDA, ANADA, CMC, DMF, CBE, ADE and annual product review and trending reports.• Review of all CMC and clinical submission documents.• Prepare product labels and site master file. • Represents RA in multifunction project team meetings and advises team on RA pathway and studies & documentation needed for submissions. • Writes and reviews SOP related to cGMP/cGLP regulations, quality system, equipment profiles and equipment IQ/OQ/PQ-s and analytical methods.• Writes and reviews investigations, method development and validation protocols, stability profiles and protocols.• Familiar with FDA regulations, guides and directives, especially with the ones related to Rx drugs and cGMP/cGLP.

• Performed drug chemical analysis on finished products and raw materials using wet chemistry, HPLC, UV-VIS, AA, TLC, IR, dissolution apparatus, KF titrino, viscosimeters, etc. • Performed analytical method development and validation, write analytical method SOPs and validation protocols, performed analytical equipment qualifications and calibrations.

• Prepared Drug Applications for Marketing Licenses. The company produced a range of about 400 generic Rx drug products, and exported in Eastern Europe, North Africa, Asia. • Prepared chemical and pharmacological parts of the drug applications including product composition, raw materials, specifications and methods of analysis of the raw materials. • Detailed description step by step of the production process and equipments, specifications and methods of analysis of the intermediate and finished products, stability data, summary of the product characteristics, patient information leaflet, pharmacological and toxicological data, bioavailability and bioequivalence studies for orally administered drugs, information about the packaging materials. • The applications were prepared by gathering information from all the different departments of the company and by consulting EP, BP, USP and different physician’s books. The applications were prepared in English.

• Performed drug chemical analyses and review of the CMC section of Drug Applications for Marketing Licenses submitted by Albanian or international pharmaceutical companies. • Performed drug chemical analyses on different forms and doses of Rx or OTC drugs (tablets, capsules, creams and pomades, injections, oral solutions, inhalations, raw materials, etc.) using wet chemistry, HPLC, UV-VIS, AA, TLC, IR, titra-lab, KF, dissolution apparatus, etc. according to EP, BP, and USP and in several cases Italian Pharmacopoeia, French Pharmacopoeia and Swiss Pharmacopoeia. • Performed analytical method development and validation, equipment qualifications and calibrations.

Master Of Science, Natural Products

Industrial Chemist, Industrial Chemistry