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General Regulatory Strategy

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At Syner-G, our regulatory professionals are adept at navigating and overseeing every facet of your drug development program’s regulatory requirements. This includes crafting comprehensive global regulatory strategies, representing your interests on product development teams, managing IND/CTA submissions and upkeep of submissions with product changes, supporting marketing authorization, and facilitating interactions with global Regulatory Agencies.

Virtual Regulatory Department for Smaller Organizations

For smaller companies, especially those based outside the US looking to initiate clinical trials in the US, Syner-G often serves as a dual-function resource: a virtual, highly experienced regulatory department and a designated US Agent. Our full-service approach provides top-notch regulatory expertise from experienced multi-faceted professionals and comprehensive end-to-end support, from initial Regulatory Agency engagement to trial completion. This model enables our clients to utilize our vast knowledge and experience while saving on the costs associated with maintaining a full-time, in-house regulatory team. As your US Agent, we ensure seamless communication with the FDA and adherence to US regulatory pathways, offering an essential service for ex-US companies to successfully navigate the complexities of the US clinical trial environment without the overhead of expanding their teams.

Global Regulatory Strategy and Non-US Expertise Strategic Development

As a drug candidate transitions from research to development, the formulation of a robust global regulatory strategy is imperative. At Syner-G, we provide comprehensive support, crafting regulatory roadmaps that navigate our clients through the process that spans from early development through to registration. Our expertise extends to identifying pivotal opportunities for strategic regulatory designations that can accelerate development. We also specialize in planning key strategic global regulatory meetings and outlining country specific requirements for CTAs that are critical for advancing your product strategy. Our strategies are meticulously designed to gain consensus across all tiers of your product development team, ensuring a harmonious and strategic path forward that can meet patient needs in a timely manner.

Regulatory Agency Meetings and Preparation

Interacting effectively with global regulatory agencies like the FDA, EMA, and MHRA among others, is a critical component of any successful drug development program. At Syner-G, we not only help prepare strategic questions and comprehensive briefing packages but also actively participate in these crucial meetings. Our experience has given us deep insights into what makes these interactions successful, helping to smooth the path for your product’s approval process.

Our Meeting Support Services Include:

  • Briefing Document Coordination and Preparation: Crafting strategic questions and comprehensive briefing packages tailored to the specifics of your product
  • Preparation and Coaching: Thorough coaching of your team to excel in regulatory agency interactions
  • Sponsor Representation and Meeting Logistics: Acting as your representative at meetings and handling all logistical aspects to ensure smooth proceedings
  • Meeting Follow-Up:Providing comprehensive follow-up services including detailed analysis of the discussions, meeting minutes, and managing any disputes that arise

Beyond the core activities, Syner-G offers a suite of additional consulting services to enhance your product's market strategy:

  • Labeling Strategy and Target Product Profiles: Developing strategic labeling to maximize product potential and compliance
  • Gap assessments/risk mitigation plans
  • US Agent role of ex-US companies
  • Orphan Drug Strategies: Specialized strategies to navigate the regulatory pathways for orphan drugs
  • Pediatric Development Plans: Tailored strategies for pediatric drug development
  • Accelerated Drug Development Strategies: Including pathways like Fast Track, PRIME, and Breakthrough Therapy designations to expedite your product’s market entry

Comprehensive Support for Product Development Teams

As part of our comprehensive services, Syner-G frequently acts as the regulatory affairs arm of product development teams. We provide both strategic and operational regulatory expertise and often lead regulatory sub-teams. These sub-teams might include experts from various technical areas such as CMC, clinical/nonclinical strategy, regulatory operations, and labeling, depending on the development stage of the product.

IND/CTA and NDA/BLA/MAA Submission Coordination

Our regulatory affairs professionals coordinate the development of key messages along with the drafting and submission of initial INDs/CTAs, IND amendments, and marketing authorization applications (NDA/BLA/MAA). A cornerstone of our service is to ensure that your regulatory strategies are robust and compliant with global regulatory requirements. Syner-G is also proud to often serve as the authorized representative for our clients with the US FDA.

International Consulting

Should your project target international markets, we utilize our broad network of regulatory affairs specialists outside the US to offer you bespoke consulting and manage your regulatory submissions and operations abroad. This global perspective ensures that strategic plans are well-rounded and inclusive of international regulatory landscapes.

Choose Syner-G as Your Partner

Choosing Syner-G BioPharma Group means partnering with a leader in regulatory strategy and submission who is committed to your project’s success from conception to approval. Our approach integrates profound regulatory knowledge with a commitment to compliance and strategic innovation, ensuring that your products not only meet all regulatory standards but also achieve their market potential efficiently.

Join us and let Syner-G navigate the regulatory landscape for you, ensuring clarity, compliance, and speed to market.