Grayscale can help.
About Grayscale Compliance
Grayscale Compliance is a consulting practice owned and operated by John Murray, an expert in FDA regulation of prescription drug and biologic advertising and promotion.
Drug and biologic companies are challenged more than ever with growing commercial pressures and an intensifying regulatory and compliance environment. FDA and other government enforcement efforts routinely focus on “gray” areas of the laws and regulations. While laws and regulations are plainly printed in black and white, enforcement and interpretation can seem anything but....
Grayscale Compliance can help you with both routine and non-routine issues in complying laws and regulations typically overseen by FDA’s DDMAC or APLB enforcement divisions. Grayscale can also help you with the increasing challenges of integrating FDA compliance issues with more established Health Care or Corporate compliance programs.
Get effective and cost-effective help from someone who’s been in your shoes and can bring a deep and broad range of expertise and perspectives to your challenges. Whether you need open-minded thinking, or just a black letter regulatory analysis, Grayscale Compliance can help.
As an employee of Johnson & Johnson/Centocor, AstraZeneca and Astra Merck, John has successfully managed compliance operations, promotional regulatory departments and teams, and regulatory issues for some of the most complex and successful biologic and drug products. Beginning in 2008 John has managed a successful consulting practice that leverages experience, expert knowledge, preparation, and creativity to help clients successfully manage routine and non-routine regulatory and compliance issues.
Drug and biologic companies are challenged more than ever with growing commercial pressures and an intensifying regulatory and compliance environment. FDA and other government enforcement efforts routinely focus on “gray” areas of the laws and regulations. While laws and regulations are plainly printed in black and white, enforcement and interpretation can seem anything but....
Grayscale Compliance can help you with both routine and non-routine issues in complying laws and regulations typically overseen by FDA’s DDMAC or APLB enforcement divisions. Grayscale can also help you with the increasing challenges of integrating FDA compliance issues with more established Health Care or Corporate compliance programs.
Get effective and cost-effective help from someone who’s been in your shoes and can bring a deep and broad range of expertise and perspectives to your challenges. Whether you need open-minded thinking, or just a black letter regulatory analysis, Grayscale Compliance can help.
As an employee of Johnson & Johnson/Centocor, AstraZeneca and Astra Merck, John has successfully managed compliance operations, promotional regulatory departments and teams, and regulatory issues for some of the most complex and successful biologic and drug products. Beginning in 2008 John has managed a successful consulting practice that leverages experience, expert knowledge, preparation, and creativity to help clients successfully manage routine and non-routine regulatory and compliance issues.
Expert Analyses and Regulatory Opinions
If you need help analyzing or managing a complex or even routine issue related to FDA’s regulation of your product promotion, Grayscale can provide written reports, research, opinions or any other kind of consultation. Grayscale Compliance can help you to:
- Manage enforcement actions
- Successfully navigate advisory comment processes with DDMAC, APLB or other divisions
- Analyze complex regulatory challenges with new media or unique business strategies
- Conduct risk assessments for products and promotional strategies
- Reviews of business plans to identify potential misbranding issues
- Evaluate substantiation for promotional claims and potential clinical studies
- Integrating FDA compliance elements into Healthcare Compliance or Corporate Compliance programs
- Communicating safety information and fair balance more effectively and in harmony with your promotional campaign
- Creating communication plans under REMS requirements
- Managing regulatory compliance with speaker programs
- Managing FDA safe harbors and liabilities with medical affairs activities (KOL interactions, responding to unsolicited requests, deployment of medical science liaisons, clinical trial recruiting activities, policy and process development and evaluation, and other issues)
Training Programs
When you are running a compliance program, you can often feel like you're chasing your tail managing a myriad of infractions that seem unnecessary and avoidable at times. You can put out one policy after another, but teaching people simple judgement in a complex business environment can go much further to creating a culture of compliance. Simulations and role plays cannot possibly reflect the infinite amount of complex and sometimes unbelievable circumstances your employees can be faced with. Training programs need to deliver not only the sound basics of compliance and regulations, but a solid understanding and respect for laws and regulations designed to protect the public health. The government exercises significant discretion in its enforcement and prosecution. Each and every day employees navigate through situations governed by a vast network of laws and regulations comprehensible only to lawyers and experts. Good training and good education can keep real world decisions of employees on the right side of enforcement discretion.
Grayscale Compliance can help you to get both basic and advanced training up and running to meet your unique business challenges and help you to focus on other areas of building your program.
Grayscale Compliance specializes in FDA advertising and compliance training for sales representatives, medical affairs, marketing, vendors and agencies and other targeted programs. Whether you need general training or on programs for specific issues (eg, claims substantiation or MSL training), we can help.
Grayscale Compliance can help you to get both basic and advanced training up and running to meet your unique business challenges and help you to focus on other areas of building your program.
Grayscale Compliance specializes in FDA advertising and compliance training for sales representatives, medical affairs, marketing, vendors and agencies and other targeted programs. Whether you need general training or on programs for specific issues (eg, claims substantiation or MSL training), we can help.
Copy Approval Services
Medical, Legal, and Regulatory review committees or Copy Approval committees and similar processes are perhaps among the most important business and risk management functions in a company. As a function, they can ironically often seem dysfunctional. Yet, in spite of the inherent challenges in all review and approval processes, most represent a high level of decision making and risk assessment that is often taken for granted.
Nonetheless, copy approval processes are resource-intensive and require excellent regulatory knowledge, business knowledge, and a high demand for good communication and interpersonal skills. Grayscale Compliance can provide both short-term and long-term copy approval services when you need additional expertise or you need resources for whom you can trust will make good and informed regulatory decisions.
Grayscale Compliance represents 15 years of copy approval experience for your teams and can bring both a current and historical industry-wide perspective on regulatory decisions. With a broad base of current clients and a long history of experience in the most well-respected medical product companies, Grayscale provides a regulatory compass for routine and non-routine copy approval decisions. Grayscale can work in existing electronic commenting systems, provide off-line or hard copy comments and can participate in regular committee meetings. Services will be tailored to your needs.
Grayscale can also help with:
Nonetheless, copy approval processes are resource-intensive and require excellent regulatory knowledge, business knowledge, and a high demand for good communication and interpersonal skills. Grayscale Compliance can provide both short-term and long-term copy approval services when you need additional expertise or you need resources for whom you can trust will make good and informed regulatory decisions.
Grayscale Compliance represents 15 years of copy approval experience for your teams and can bring both a current and historical industry-wide perspective on regulatory decisions. With a broad base of current clients and a long history of experience in the most well-respected medical product companies, Grayscale provides a regulatory compass for routine and non-routine copy approval decisions. Grayscale can work in existing electronic commenting systems, provide off-line or hard copy comments and can participate in regular committee meetings. Services will be tailored to your needs.
Grayscale can also help with:
- Copy approval process assessments and audits
- Development of promotional guidelines or policies
- Training for reviewers, agencies, product managers or other review material sponsors
- Development of job aids for reviewers, product managers or other review material sponsors
Assistance with Launch Campaigns
Launch activities are fraught with expectations and that means a lot of pressure on regulatory to succeed and do it fast. If you're seeking help managing advisory comments from FDA and the associated procedures, get experience from someone who has successfully launched some of the largest and most successful products. Advice, sanity checks, and expert opinions can be helpful, but you also need someone who understands the business pressures and business needs to succeed and stay in line with regulatory requirements. Call on Grayscale Compliance for overall management or for expert opinions and advice.
Compliance Audits or Document Reviews
Compliance programs require sound processes and procedures that are actually followed. Assessments and audits of processes and procedures are key to compliance program management. Grayscale Compliance can help with process assessments and document reviews for monitoring programs and business and strategic planning.
Development of Policies and Procedures
Grayscale Compliance can help you to develop policies and procedures to ensure proper promotion of FDA-regulated products. This includes both detailed policy development and easy-to-understand summaries for employees and the companies vendors or agents. Grayscale Compliance can assess your current policies and fill in the gaps or suggest improvements to meet your program or business needs.
Monitoring Programs for Off Label Promotion or Other Compliance Program Issues
Grayscale Compliance specializes in helping companies to stay on the right side of FDA and other government enforcement of drug, biologic, and medical device misbranding issues. Monitoring programs are essential to maintaining and validating the effectiveness of your compliance program. Government enforcement focuses on far more than what comes through your copy approval committees. Representative statements, business and marketing plans, vendor proposals and communications and virtually anything else the goverment can get their hands on have become the cornerstone of the governments determinations of a company's intended uses for FDA regulated products. The varied sources and forms of potential evidence of misbranding are scattered all over your company. Grayscale Compliance can help you to develop effective strategies to harness the sources of information that can tell the good story about your company's behavior and to detect areas of trouble or potential trouble.