We are experts at developing and implementing cGMP quality systems for the FDA regulated industry. We primarily focus on: Branded and generic drugs, compounded drugs, and OTC drugs.Current engagements include:- FDA Warning Letter remediation for a sterile and non-sterile drug manufacturer - Quality expert for a Covid-19 diagnostic kit manufacturer and three sterile and non-sterile drug manufacturing companies- Have performed over 350 audits for branded and generic drugs, OTC drugs, compounded drugs, APIs, medical devices, cosmetics, and dietary supplements against 210/211, ICH Q7, ICH Q10, ISO 9001, ISO 13485, ISO 22716, WHO, Health Canada, and EU standards. Visit us at https://steripharmsolutions.com

• Led the development and execution of quality policies and procedures at Harrow Health's compounded drug facilities. Served as the company’s primary contact with the FDA and other regulatory authorities, hosted audits and inspections, and designed and implemented remediation plans. • Ensured compliance with Sections 503A and 503B and 21 CFR Parts 210 and 211 at all compounded drug sites. Oversaw product and raw materials disposition at a New Jersey 503B facility.• Managed 5 reports and 8 external consultants, while reporting directly to the CEO. Conducted company-wide training for cGMP, GDP and FDA readiness. Delivered regular updates regarding quality to the Board of Directors. • Developed and implemented quality assurance, quality control, and validation systems for a new 503B sterile manufacturing outsourcing facility in New Jersey. Secured wholesale licensing from 47 state pharmacy boards and the DEA for Schedule III controlled substances. Launched 13 sterile ophthalmic injectables and drops during year one, driving exponential growth that now contributes 80% of the total company revenue. • Led successful discussions with the Center for Drug Evaluation and Research regarding recalls and sample testing for Adverse Drug Events submitted through the Safety Reporting Portal.• Established a supplier qualification program to meet Federal requirements and conducted audits of key vendors. Developed cGMP systems from scratch to meet all regulatory requirements and ensure ongoing company growth.• Rapid remediation of Warning Letters for 503A sites in California and Pennsylvania. • Managed testing and stability programs at 5 third-party contract labs. Managed key relationships with the CEOs and Owners of laboratories, and successfully implemented a competitive testing cost structure.

• Responsible for leading quality and technical oversight for process validation initiatives and served as subject matter expert for sterile products. Managed 5 direct reports within Alvogen facilities across New York and New Jersey. Played a key role in a critical injectable launch and 3 successful ANDA approvals.• Managed 34 projects and partnerships with CMOs in the Americas, Europe, and India. Provided oversight and support for Stage 1 and Stage 2 Process Validations, CRLs, PAIs, and regulatory submissions. • Developed and managed quality systems governing internal and external product development. Drug products included: sterile injectables, ophthalmic and otic drops, non-sterile oral (solid and liquid), topical (ointments, gels, and creams), and transdermal and transmucosal dosage forms.• Conducted regular internal audits for R&D and Site Transfer groups, along with external audits involving key CMOs. Supported senior leadership on product and partnership due diligence in France and Italy.

• Led quality for the AMRI facility in Burlington, MA, and served as the Chair of the Site Quality Council. Responsible for QA/QC, validation, quality agreements, supplier qualification, audits, and regulatory inspections. Played a key role in $2M revenue realization from a new account within the first quarter, three back-to-back profitable quarters, and a 100% increase in business. • Managed 5 direct reports, a team of 38 personnel, and an annual budget of $3.5M. Acted as the main quality point of contact for 20 customers; assisted 4 customers with FDA responses, resulting in successful NDA, IND, and PMA.• Within the first 60 days in role, eliminated a backlog of 95+ investigations from 2013 and 2014. Reviewed and approved over 500 investigations, deviations, and CAPAs to maintain over dues in the single digits or low teens.• Led successful FDA (cGMP and PAI) and DEA inspections and guided the site’s first NDA approval for commercial distribution of an injectable. Hosted 7 successful customer and third-party audits for small molecules and biologics, including a QP audit for the EU importation of a veterinary medicine product.• Responsible for clinical and commercial processes for aseptic fill/finish for complex sterile liquid and lyophilized parenteral formulations, vials, and syringes. Formulations and products included biologics, small molecules, potent and cytotoxic drugs, and controlled substances up to Schedule II and IIN.• Identified and integrated new concepts and technologies for the EM program, which included gaseous (VHP®) decontamination of the entire aseptic manufacturing area.

• Managed and measured compliance for all internal and regulatory requirements, mitigation plans, and problem resolution across all domestic and international facilities. Managed a global team of 8 managers and specialists. • Managed the Internal Audit Program governing all global sites, as well as external inspection readiness and support. The scope of internal audits included comprehensive processes, products, quality systems, pharmacovigilance (PV), design and development, suppliers, and regulatory filings.

• Led daily quality oversight for operations, QC, research and development functions, 14 personnel and contractors, and an annual budget of $1.5M. Reviewed and released raw materials, packaging components, in-process materials, and finished products. Achieved over 10x business growth via product launches, site transfers, and increased batch sizes. • Served as FDA host for a full range of GMP and pre-approval inspections and customer/third-party GxP audits. As QA Manager and QA Director, managed 7 successful FDA inspections (3 with zero observations), 10 successful customer audits, and 5 successful retail certification audits for OTC drugs. • While in the site leadership role, achieved a 17 to 21-day fill to release time for over 400 finished product batches (16 million+ commercial units) per year, 0.1 deviations and 0.02 OOS per batch, 1 customer complaint per 100,000 sold units, and more than 90% of all investigations closed within 30 days.• Qualified and validated a $26M expansion and modernization project, which included cleanrooms, enhanced formulation capacity, water-for-injection, pure steam, clean compressed air, and autoclaves.• Reviewed and approved all exception reports, changes, and annual product reviews (APRs). Directly managed all validation activities, including process validations and annual re-qualifications.• Provided critical contributions for successful CBE supplements (CBE-0, CBE-30), NDA, ANDA (solution, ointment) and ANADA submissions, and deficiency responses. Managed successful submissions to Health Canada for both a prescription and an OTC product.