Customized Regulatory Monitoring: We monitor regulatory developments that impact our clients’ products and business interests, providing regular updates on changes in regulations, guidelines, and policies. We customize our monitoring based on our clients’ specific needs and interests, providing them with the information that is most relevant to their business.

Regulatory Analysis and Interpretation: We analyze regulatory changes and provide our clients with a clear understanding of the potential impact on their products and business. We help our clients understand the regulatory requirements and implications of the changes, and provide guidance on how to stay compliant.

Regulatory Training: We offer customized regulatory training to our clients, helping them understand the regulatory landscape and stay up-to-date on regulatory changes. Our training is tailored to our clients’ specific needs and includes a range of topics, from basic regulatory concepts to advanced regulatory compliance strategies.

Regulatory Strategy Development: We work with our clients to develop regulatory strategies that align with their business objectives and regulatory requirements. Our team of experts provides guidance on how to navigate the regulatory landscape, minimize risks, and optimize regulatory compliance.

Regulatory Submissions Support: We provide regulatory submissions support, including regulatory writing and review services, to help our clients prepare high-quality submissions that meet regulatory requirements.

Regulatory Strategy Development: We work with our clients to develop a regulatory strategy that aligns with their product development goals and regulatory requirements. Our team of experts provides guidance on how to navigate the regulatory landscape, minimize risks, and optimize regulatory compliance.

Regulatory Planning and Project Management: We provide regulatory planning and project management services to help our clients manage the regulatory process efficiently and effectively. We help our clients develop a comprehensive regulatory plan, identify and manage regulatory risks, and ensure timely regulatory submissions.

Regulatory Submissions: We provide support for regulatory submissions, including preparation, review, and submission of regulatory documents. Our team of experts has extensive experience with all types of regulatory submissions, including INDs, NDAs, BLAs, and PMAs.

Labeling and Advertising: We provide guidance on labeling and advertising requirements, ensuring that our clients’ products are marketed in compliance with regulatory requirements. We also provide support for review and approval of labeling and advertising materials.

Regulatory Strategy Development: We work with our clients to develop a regulatory strategy that aligns with their product registration goals and regulatory requirements. Our team of experts provides guidance on how to navigate the regulatory landscape, minimize risks, and optimize regulatory compliance for successful product registration.

Regulatory Planning and Project Management: We provide regulatory planning and project management services to help our clients manage the regulatory process efficiently and effectively. We help our clients develop a comprehensive regulatory plan, identify and manage regulatory risks, and ensure timely regulatory submissions for successful product registration.

Regulatory Submissions: We provide support for regulatory submissions, including preparation, review, and submission of regulatory documents. Our team of experts has extensive experience with all types of regulatory submissions, including 510(k), PMA, IDE, and CE Mark applications for successful product registration.

Regulatory Compliance: We provide regulatory compliance support throughout the product lifecycle, including compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) requirements. We help our clients prepare for regulatory inspections and audits, and provide guidance on remediation activities when necessary for successful product registration.

Post-Approval Compliance: We provide post-approval compliance support, including monitoring of adverse events, regulatory reporting, and post-market surveillance. We help our clients maintain regulatory compliance and ensure product safety and efficacy for successful product registration.

Investigational New Drug (IND) applications: Companies must submit IND applications to the US Food and Drug Administration (FDA) before conducting clinical trials of new drugs. The IND application contains detailed information about the drug’s chemistry, manufacturing, and controls (CMC), as well as preclinical and clinical data.

New Drug Applications (NDAs): NDAs are submitted to the FDA when a company seeks approval to market a new drug in the United States. The NDA contains extensive data on the drug’s safety and efficacy, as well as information about its manufacturing, labeling, and post-market surveillance.

Marketing Authorization Applications (MAAs): MAAs are similar to NDAs but are submitted to regulatory agencies in other countries. Companies must provide detailed information about their products and demonstrate their safety and efficacy to obtain marketing authorization.

Annual reports: Companies must submit annual reports to regulatory agencies to provide updates on the safety and efficacy of their products.

Lifecycle management: We provide support to companies to manage their products throughout the product lifecycle, including managing changes in product formulations, manufacturing processes, and labeling, as well as addressing safety concerns, and managing adverse events.

Annual reports: We assist companies in preparing and submitting annual reports to regulatory agencies, which provide updates on the safety and efficacy of the product and its continued compliance with regulatory requirements.

Renewals and re-registration: We provide support in the preparation and submission of renewal and re-registration applications for products that require periodic renewals or re-registration.

Post-approval changes: We assist companies in managing post-approval changes to the product, including changes to manufacturing processes, labeling, or other product aspects, as well as in managing post-approval commitments to regulatory agencies.

Scientific Exchange: We facilitate scientific exchange between our clients and KOLs, helping our clients communicate the latest scientific data and evidence supporting their products. Our team has experience developing and delivering scientific presentations, webinars, and other scientific communication materials.

MSL Recruitment: We help our clients recruit and hire MSLs who have the scientific expertise, communication skills, and professional experience necessary to succeed in the role. Our team has experience recruiting MSLs in a wide range of therapeutic areas and can help clients develop a recruitment strategy that is tailored to their specific needs.

MSL Training: We provide comprehensive training programs to help MSLs develop the scientific and communication skills necessary to effectively engage with healthcare professionals. Our team has experience developing and delivering training programs that are effective and engaging, using a variety of training methods and platforms.

KOL Management: We help MSLs build and maintain relationships with key opinion leaders (KOLs) in their therapeutic areas, providing support and guidance to help MSLs effectively engage with KOLs and communicate the latest scientific data and evidence supporting their products.

Scientific Communication: We help MSLs develop and deliver scientific presentations, webinars, and other scientific communication materials that effectively communicate the latest scientific data and evidence supporting our clients’ products.

Needs Assessment: We conduct comprehensive needs assessments to help our clients identify the knowledge and skill gaps of their target audiences, which helps inform the development of effective medical education programs.

Curriculum Development: We work with our clients to develop comprehensive medical education curriculums that are tailored to the needs of their target audiences. Our team has experience developing curriculums for a wide range of healthcare professionals, including physicians, nurses, and pharmacists.

Educational Content Development: We develop engaging and effective educational content, including e-learning modules, webinars, and live events, to deliver the latest scientific data and evidence supporting our clients’ products.

Accreditation and Compliance: We ensure that all of our educational programs comply with the relevant accreditation requirements and guidelines, ensuring that healthcare professionals receive continuing education credits for participating in our programs.

Evaluation and Outcomes Measurement: We conduct rigorous evaluations of our educational programs to ensure that they are effective in improving the knowledge and skills of healthcare professionals. Our team has experience conducting outcomes-based evaluations, which help our clients measure the impact of their educational programs on patient outcomes.

Process Improvement: We help our clients identify opportunities for process improvement, develop and implement new processes, and optimize existing processes to improve operational efficiency and effectiveness.

Supply Chain Management: We help our clients manage their supply chain to ensure that the right products are available at the right time and at the right cost. Our team has experience developing and implementing supply chain strategies that improve operational efficiency while maintaining high levels of quality.

Quality Management: We help our clients implement and maintain effective quality management systems that ensure that their products and services meet regulatory requirements and quality standards. Our team has experience developing and implementing quality management systems in a wide range of therapeutic areas.

Project Management: We help our clients manage complex projects, from product development to clinical trials to post-market surveillance. Our team has experience managing projects of all sizes, ensuring that they are delivered on time, on budget, and with high levels of quality.

Change Management: We help our clients manage organizational change, including mergers and acquisitions, restructuring, and process changes. Our team has experience developing and implementing change management strategies that minimize disruption and ensure a smooth transition.

Promotional Review: We provide expert review of promotional materials, including sales aids, brochures, websites, and other promotional activities, to ensure that they comply with regulatory requirements and ethical standards. Our team has experience working with pharmaceutical and medical device companies in a wide range of therapeutic areas, ensuring that promotional materials are effective and compliant.

Non-Promotional Review: We provide expert review of non-promotional activities, including medical education programs, scientific publications, and advisory boards, to ensure that they comply with regulatory requirements and ethical standards. Our team has experience working with medical affairs and marketing teams to develop and execute effective non-promotional activities that support product education and patient care.

Training and Education: We provide training and education to our clients on regulatory requirements and ethical standards related to promotional and non-promotional activities. Our team has experience developing and delivering customized training programs for pharmaceutical and medical device companies of all sizes.

Compliance Monitoring: We provide ongoing monitoring of promotional and non-promotional activities to ensure that our clients remain compliant with regulatory requirements and ethical standards. Our team has experience working with healthcare compliance teams to develop and implement compliance monitoring programs that identify and mitigate compliance risks.