Easy FDA Compliance, Drug, OTC, Cosmetic Registration, Regulatory Consulting & Audits.
Certifications
Doctor of Pharmacy
Pharmaceutical Regulatory Specialist
These certifications demonstrate a strong foundation in the pharmaceutical field and a specialization in navigating regulatory landscapes. A Doctorate degree in Pharmaceutical Science provides essential knowledge about drug development, formulation, and quality assurance, while the Pharmaceutical Regulatory Specialist certification highlights expertise in compliance with FDA regulations and guidelines. Together, they equip professionals to effectively manage the complexities of pharmaceutical regulations and ensure successful drug listings and approvals.
Dr. Dyana Rios PharmD, BSPharm, BCMAS, PACS, PRS
Our Services Focus On FDA Compliant Reporting & Submissions
Navigating Regulatory Waters, Ensuring Pharmaceutical Excellence
Client Feedback & Journeys
FDA Audit Preparation and Remediation
Scenario: A pharmaceutical company faced an upcoming FDA inspection and needed to ensure compliance.
Solution: Pharma Compliance Consultants conducted mock audits, identified gaps in compliance, and provided training to the client's staff. Post-inspection, the company received an FDA Form 483. Pharma Compliance Consultants performed a root cause analysis, developed corrective actions (CAPA), and assisted in responding to the FDA.
Outcome: The client successfully resolved the 483 observations, avoiding further regulatory action.
503B Outsourcing Facility Compliance
Scenario: A 503B outsourcing facility needed ongoing assistance with FDA compliance, particularly with drug reporting and facility registration.
Solution: Pharma Compliance Consultants guided the client through facility registration, obtained NDC codes, and handled biannual drug product reports via eDRLS. The team ensured that the facility met all FDA 503B outsourcing facility requirements.
Outcome: The client maintained compliance, preventing any operational disruptions or regulatory violations.
OTC Drug Labeling Compliance
Scenario: A client producing over-the-counter (OTC) drugs needed to ensure their product labels complied with FDA 503B requirements and OTC monographs.
Solution: Pharma Compliance Consultants reviewed the labels, identified any areas of non-compliance, and worked with the client to revise them according to FDA standards.
Outcome: The client achieved fully compliant product labeling, reducing the risk of regulatory issues or product recalls.ANDA Submission for Generic Drugs
Scenario: A small pharmaceutical company needed help with submitting an Abbreviated New Drug Application (ANDA) for a generic drug.
Solution: Pharma Compliance Consultants assisted with the ANDA submission, ensuring that the application met all regulatory requirements, including GDUFA fees, and managed communications with the FDA.
Outcome: The ANDA was successfully approved, allowing the client to enter the generic drug market.
ANDA Submission for Generic Drugs
Scenario: A small pharmaceutical company needed help with submitting an Abbreviated New Drug Application (ANDA) for a generic drug.
Solution: Pharma Compliance Consultants assisted with the ANDA submission, ensuring that the application met all regulatory requirements, including GDUFA fees, and managed communications with the FDA.
Outcome: The ANDA was successfully approved, allowing the client to enter the generic drug market.
Cosmetic MOCRA Compliance for New Product Launch
Scenario: A cosmetics company needed help ensuring compliance with the new Modernization of Cosmetics Regulation Act (MOCRA) for their new product line.
Solution: Pharma Compliance Consultants provided guidance on MOCRA regulations, including proper ingredient disclosure, labeling compliance, and post-market surveillance.
Outcome: The company successfully launched their new product line without delays or regulatory issues.
Client Reviews
“Pharma Compliance Consultants delivered exceptional service for our drug establishment registration and listing needs! Their expertise and attention to detail ensured that our submissions were thorough and compliant with FDA regulations. They managed the entire process smoothly, from initial registration to ongoing updates, allowing us to focus on our core operations. Their team was responsive, knowledgeable, and dedicated to helping us meet our regulatory requirements efficiently. I highly recommend Pharma Compliance Consultants for anyone needing reliable and expert support in drug establishment registration and listing services. Their professionalism truly sets them apart!”
Lisa Peter
“Pharma Compliance Consultants exceeded our expectations! We needed help with regulatory licensing, registrations, and drug listings, and their team provided exceptional support every step of the way. Their expertise in navigating complex FDA requirements is impressive, and they made the entire process smooth and stress-free. The communication was clear, prompt, and professional, and they delivered everything within the promised timelines. If you're looking for a reliable partner for FDA compliance, I highly recommend Pharma Compliance Consultants!”
Jane Lucas
“Pharma Compliance Consultants went above and beyond with their exceptional SOP writing services. Their team demonstrated deep industry knowledge and created clear, compliant, and well-structured SOPs tailored perfectly to our needs. The process was smooth, professional, and thorough from start to finish. They took the time to understand our unique requirements and delivered high-quality documents that have significantly improved our operational efficiency. We highly recommend Pharma Compliance Consultants for anyone looking for top-notch SOP writing and compliance support!”
Devin Travis
Contact us
If you have any questions or comments, please contact us via email or phone, or send us a message using the contact form.
Email
PharmaCompConsultants@gmail.com
Phone
(914) 204 9004
Social