Pharmaceutical Development Consulting

You can rely on our regulatory intelligence as well as on the experience and expertise of our consultants for the success of your project.

Pharmaceutical Development Consulting

Our team of experienced consultants, coupled with our regulatory expertise, is dedicated to ensuring the success of your project. At VMG Global Cure, we offer comprehensive services that cover every stage of your drug development journey, from initial product development to authorization and beyond.

Our services encompass:

1. Licensing and Investment Decision Support:
– Conducting due diligence for informed licensing and investment choices.

2. Strategic Expertise and Regulatory Advice:
– Providing expert input and regulatory guidance across various domains, including Chemistry Manufacturing and Controls (CMC), non-clinical studies, clinical trials, efficacy, and safety.
– Assisting with data assessment, interpretation, and positioning.

3. Global Development Planning and Regulatory Strategy:
– Offering advice on global development plans, including integration of value-based pay evidence requirements.
– Crafting global regulatory strategies and facilitating meetings with regulators and payers.

 

4. Scientific Writing of Regulatory Documents:
– Preparing high-quality regulatory documents for EU and US submissions, such as briefing documents for scientific advice, Orphan Drug Designation (ODD), Pediatric Investigation Plan (PIP), Investigation al Medicinal Product Dossier (IMPD), Investigational New Drug (IND), Clinical study reports, Marketing Authorization Application (MAA), and New Drug Application (NDA) / Biologics License Application (BLA) modules.
– Developing responses to agency questions (RTQ).

5. Scientific Writing of Pharmacological and Safety Documents:
– Creating comprehensive documents, including Risk Management Plans (RMP), Development Safety Update Reports (DSURs), and Periodic Benefit Risk Evaluation Reports (PBRERs).

6. Operational Support and Regulatory Project Management:
– Providing operational support and project management for various regulatory activities, including ODD, PIP, scientific advice, IMPD, IND, Clinical Trial Applications (CTAs), Clinical Study Reports (CSRs), and DSURs.
– Assisting with regulatory publishing.

7. Development of Client-Customized Operational Platforms:
– Developing tailored operational platforms to meet the specific needs of our clients.

Count on VMG Global Cure to deliver comprehensive drug development consulting services, tailored to your project’s requirements, and guided by our regulatory intelligence and experienced consultants.

Drug Development Consulting

Drug Development Strategy

At VMG Global Cure, our Global Regulatory Services team comprises Consultants with vast experience in European Medicines Agency (EMA), Food and Drug Administration (FDA), and National Regulatory Agencies. They are equipped to offer valuable advice and recommendations, ensuring the shortest possible time to market by minimizing potential barriers.

Our team of experts is dedicated to helping you navigate new and existing guidelines, ensuring that your medicinal product complies with all regulatory requirements. We provide comprehensive support for your product’s development strategy, starting from the early phases and extending all the way to the submission for marketing authorization.

 

In addition, VMG Global Cure excels at formulating effective regulatory strategies that align with both your company’s objectives and regulatory standards. These strategies facilitate post-approval activities seamlessly. We can prepare or review submissions, conduct thorough gap analyses and risk assessments prior to submission, and anticipate potential questions from Health Authorities. By doing so, we ensure that you are well-prepared to provide prompt and accurate responses.

Furthermore, our team at VMG Global Cure can assist you with quality control and the publishing of regulatory submissions, as well as help you prepare for Agency meetings. We are committed to supporting your drug development journey at every stage.