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Regulatory Strategy & Submissions

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At Syner-G BioPharma Group, we are committed to guiding our clients through the complex regulatory processes required to bring their pharmaceutical products to patients. Our dedicated team leverages extensive expertise in the regulatory landscape to provide strategic guidance and support across clinical, nonclinical, and CMC regulatory areas. This comprehensive approach ensures a unified strategy and strong engagement with global regulatory bodies, covering a vast array of therapeutic domains.

By integrating our operations closely with clients and global regulatory bodies, Syner-G ensures that each project is managed with precision within the client’s organizational culture. This approach allows for scalable and sustainable results, ultimately accelerating the market readiness of your products.

Regulatory Consulting – Your Strategic Partner from Concept to Approval

Our Regulatory Consulting services are at the heart of our operations, offering end-to-end strategic solutions designed to navigate the multifaceted world of global drug approval. The journey of drug development and approval involves meticulous planning and foresight. Syner-G’s regulatory experts excel in developing sensible, phase-appropriate strategies tailored to the lifecycle of each product. Understanding and adhering to international regulatory requirements is crucial for global market entry. By crafting detailed regulatory strategic roadmaps, including country-specific approaches for clinical trials and global registrations, we pave the way for streamlined processes and successful outcomes.

Here's a deeper look at how we tackle the
challenges and opportunities in CMC development:

Regulatory Agency Meetings and Preparation

Our regulatory consulting team provides strategic guidance and support for global health authority meetings from product conception through commercialization. Interacting effectively with global regulatory agencies such as 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.


Premier IND/CTA and BLA/NDA Strategy,
Submissions, and Management Services

Our team excels in navigating the complexities of regulatory submissions across various stages, from Investigational New Drug (IND) and Clinical Trial Application (CTA) initial submissions to Biologics License Applications (BLA), New Drug Applications (NDA), and Marketing Authorization Applications (MAA). We provide strategic guidance and phase-appropriate Common Technical Document (CTD) content for IND and CTA submissions, ensuring faster clinical trial initiation. Our regulatory strategists develop comprehensive roadmaps through pre-IND/pre-CTA meetings, culminating in successful clinical trial initiation. Additionally, our expert Global Submission Team handles authoring and publishing, ensuring accurate and compliant submissions globally. For BLA, NDA, and MAA submissions, we specialize in crafting compelling applications that highlight the safety and value of your product, accelerating your path to market approval.


Post-Approval Variation Mastery
Global Submissions Support:

Our Global Submissions Support team has the capability and experience to format, compile, publish, and submit all of your required regulatory documents to global regulatory authorities. We make hundreds of electronic submissions every year to the US FDA via the Electronic Submissions Gateway (ESG), as well as EMA and National Competent Authorities around the world. With our regulatory operations and eCTD publishing expertise, we ensure that your pharmaceutical assets progress smoothly through development hurdles and meet all necessary compliance standards for timely and high-quality submissions.


Regulatory Operations Team – Ensuring Quality and Compliance

At Syner-G, our Regulatory Operations team is pivotal in maintaining the highest standards of document quality and regulatory compliance. Through meticulous technical writing, data verification, and document quality control (QC), we ensure that every submission is crafted to meet the strictest regulatory standards.

Choosing Syner-G means partnering with a leader in drug development and regulatory strategy. Our approach combines deep regulatory expertise with a commitment to compliance and innovation in drug development. This allows us to offer not only guidance but also practical solutions that reduce risks and enhance product success in the market.

Join us at Syner-G

Where your drug development and regulatory challenges are met with advanced solutions and a dedicated team ready to assist you every step of the way. Let us help you navigate the regulatory landscape with ease and confidence, ensuring a smooth journey from laboratory to market.