DRUG REGISTRATION, LISITNG, & RECERTIFICATION
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COSMETIC REGISTRATION & LISITNGS
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FDA DEADLINES COMING SOON
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OTC LISTING & REGISTRATION
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COSMETIC FACILITY REGISTRATION
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DRUG REGISTRATION, LISITNG, & RECERTIFICATION 〰️ COSMETIC REGISTRATION & LISITNGS 〰️ FDA DEADLINES COMING SOON 〰️ OTC LISTING & REGISTRATION 〰️ COSMETIC FACILITY REGISTRATION 〰️
Our Mission
Easy FDA Compliance, Drug, OTC, Cosmetic Registration, Regulatory Consulting & Audits.
Certifications
Bachelors of Pharmaceutical Science
Pharmaceutical Regulatory Specialist
These certifications demonstrate a strong foundation in the pharmaceutical field and a specialization in navigating regulatory landscapes. A Bachelor's 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.
Dyana Rios RPh, PACS, PRS
Pharma Compliance Consulting
FDA Regulations, Drug Registration & Listing,
Drug Listing & Registration
Guidance on facility and drug registrations and compliance listings
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 Professionals 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 Professionals 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 Professionals 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 Professionals 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 Professionals 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 Professionals 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 Professionals 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.
“Pharma Compliance Professionals 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 Professionals for anyone needing reliable and expert support in drug establishment registration and listing services. Their professionalism truly sets them apart!”
Lisa Peter
“Pharma Compliance Professionals 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 Professionals!”
Jane Lucas
“Pharma Compliance Professionals 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 Professionals 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
Pharmacomppros@gmail.com
Phone
(914) 204 9004
Social
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Pharma Compliance Professionals - Frequently Asked Questions (FAQ)
1. What services does Pharma Compliance Professionals offer?
We provide a wide range of compliance services for the pharmaceutical and cosmetic industries, including:
FDA compliance guidance
503B outsourcing facility registration and reporting
Drug listing and registration
Labeling and packaging compliance
ANDA and IND submission support
MOCRA compliance for cosmetics
FDA audit preparation and 483 remediation
Quality management systems (QMS) development
Post-market surveillance and adverse event reporting
And more!
2. Who do you typically work with?
We work with pharmaceutical companies, 503B outsourcing facilities, OTC manufacturers, cosmetic brands, and any business navigating FDA regulations. Whether you’re a small startup or an established company, we can tailor our services to meet your specific regulatory needs.
3. How can Pharma Compliance Professionals help with FDA audits?
We offer comprehensive audit preparation services, including mock audits, gap assessments, and staff training. If your company receives an FDA Form 483, we help with root cause analysis, developing corrective action plans (CAPA), and preparing responses to the FDA to ensure full compliance.
4. What is MOCRA, and how can you help cosmetic companies comply?
The Modernization of Cosmetics Regulation Act (MOCRA) introduced new regulatory requirements for cosmetic manufacturers, including ingredient reporting, labeling standards, and post-market surveillance. We guide companies through the entire compliance process to ensure their products meet these updated requirements.
5. Do you assist with drug registration and listing?
Yes, we help clients prepare and submit drug registration applications, obtain NDC numbers, and maintain compliance with drug listing requirements. We also assist with annual reporting to keep registrations up to date.
6. What is a 503B outsourcing facility, and how do you support them?
A 503B outsourcing facility is a compounding pharmacy that prepares sterile drugs for distribution. We assist with the FDA registration process, ensure ongoing compliance with regulations, and handle required biannual reporting. Our goal is to help 503B facilities stay compliant and avoid regulatory issues.
7. Can you help with Abbreviated New Drug Applications (ANDA) or Investigational New Drug (IND) applications?
Absolutely! We provide end-to-end support for both ANDA and IND applications, including preparing submission documents, ensuring compliance with regulatory guidelines, and managing communications with the FDA.
8. What should we do if we receive an FDA Form 483?
If you receive an FDA Form 483, it’s important to respond promptly and accurately. Pharma Compliance Professionals can assist by performing a root cause analysis, helping you develop a CAPA plan, and guiding you through the remediation process to resolve the issues identified by the FDA.
9. How do you ensure our labeling and packaging meet FDA requirements?
We review your product labels and packaging to ensure compliance with FDA regulations, including 503B outsourcing requirements for compounded drugs, OTC drug monographs, and MOCRA standards for cosmetics. Our experts help you avoid costly recalls or rejections due to labeling errors.
10. What industries do you serve?
We primarily serve the pharmaceutical and cosmetic industries. Our expertise extends across prescription drugs, OTC products, compounding pharmacies (503B facilities), and cosmetic manufacturers looking to comply with FDA and MOCRA regulations.
11. What sets Pharma Compliance Professionals apart from other compliance service providers?
We offer tailored, hands-on support designed to meet the specific regulatory needs of our clients. Our expertise spans a wide range of FDA and global regulatory requirements, and we’re committed to providing personalized solutions that ensure your business stays compliant and successful.
12. How can we get in touch with Pharma Compliance Professionals?
You can reach us by email at pharmacomppros@gmail.com or by phone at 914-204-9004. You can also visit our website at pharmacomppros.com for more information about our services.
FAQ
FDA Compliant Reporting & Submissions
Navigating Regulatory Waters, Ensuring Pharmaceutical Excellence