Commercial End-to-End Regulatory Support
Discover how Porzio Compliance Services can support your commercial Regulatory Affairs efforts. Our team of experienced Regulatory Affairs Consultants specializes in regulatory issues related to pharmaceuticals, biotech and medical device companies at every stage of development and commercialization.
Our team of Regulatory Affairs Consultants offer a comprehensive range of services tailored to meet your specific needs, including:
- Serving as the lead Regulatory reviewer for materials review processes, both long-term and short-term assignments.
- Ad hoc Regulatory review of various internal and external materials, including promotional materials, medical/scientific content, disease education materials, social media communications, publications/abstracts, presentations, training materials, corporate websites, clinical trial materials, press releases, and labeling.
- Providing support for FDA/OPDP/APLB communications and interactions, including preparing various types of submissions to such entities, including subpart H and E, and 2253 submissions.
- Offering FDA regulatory training, guidance, and mentoring.
- Developing, supporting, and training on standard operating procedures (SOPs) to support regulatory compliance for commercial activities.
- Providing support for companies that are developing and implementing a material review process.
Providing benchmarking and advice on various regulatory topics and common challenges, such as OPDP/APLB advisory comments, presentation of efficacy and safety information, and the use of platforms/social media, and current FDA guidance.
- Tracking and providing advice on regulatory enforcement trends and activities.
Providing support for the labeling negotiations process with FDA, including communicating with FDA on same and sharing benchmarking experience.
- Launch planning including pre-approval communication plan.
- Support of all types of brands, including mature brands.
Experience the difference with Porzio Compliance Services – your trusted partner in navigating regulatory complexities and achieving compliance success.
Real-World Solutions from Porzio Compliance Services
A biotech company in phase 3 trials, heading toward submission and a planned launch, seeks MLR review support as its Marketing team develops and implements disease awareness and other materials. As the company is focusing on many other matters in preparation for a potential commercial product, our Regulatory Affairs Consultants step in to review disease awareness and pre-approval communications, and help design and implement and MLR/materials review process, and ultimately serve as the "R" in MLR to ensure material compliance for both internal and external use. Additionally, we can support the preparation of OPDP/APLB submissions to the FDA, facilitating a smooth regulatory process.
A global company has recently acquired a new product that necessitates the hiring of a sales force and significant promotional activity, including HCP and direct-to-consumer promotion. The company has not done this before and its internal Regulatory team is located outside the US. The company needs a U.S. regulatory expert to assist with setting up their review process and with the review of materials. Our Regulatory Affairs Consultants support this effort by assisting with development of a materials review SOP, conducting training, participating in the review process, and assisting with FDA/OPDP/APLB-related matters.
A commercialized pharmaceutical company has a materials review team, but one of the Regulatory reviewers will be out on leave for four months and the company does not have internal resources to fill the role. Our Regulatory Affairs Consultants are brought in to seamlessly fill this void, ensuring regulatory continuity during the reviewer's leave.
A biotech company is approaching the time where it will be involved in FDA labeling negotiations and is in need of a regulatory expert who has experience with label negotiations. Our Regulatory Affairs Consultants assist with drafting the label and providing support for the labeling negotiations process on behalf of the company.
A newly commercialized pharmaceutical company is planning a broad social media marketing campaign. Due to the nature of the product and the need to reach consumers, the company and its advertising agency have determined that social media is essential to the success of its brand. Aware of the regulatory challenges with social media and the potential regulatory risks, the company is looking for an FDA regulatory expert to guide them on this campaign. Our Regulatory Affairs Consultants advise the company on the regulatory considerations related to its social media communications and help the company prepare a compliant campaign consistent with FDA regulatory requirements.
A pre-commercial company, still in its clinical stages, would like to educate the community and HCPs on the rare disease it is investigating. Because there are limited employees, the company is looking for ways to educate on such disease state, including the mechanism of disease. Our Regulatory Affairs Consultants provide guidance and options regarding content of communications and methods for distribution.
A medical device company would like to start a new corporate media campaign that includes Key Opinion Leaders (KOLs) conducting interviews with the press regarding a commercialized product that has a pending new indication. Our Regulatory Affairs Consultants can provide talking points and train on the "do's and don'ts" of such interactions.