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Regulatory Consulting

Contact Us

Syner-G BioPharma Group’s regulatory consulting equips you with unparalleled expertise to navigate the intricate biopharmaceutical regulatory environment. We merge intelligence with strategy, transforming regulatory challenges into strategic assets. Our seasoned professionals are dedicated to your project’s success and regulatory compliance, seamlessly advancing from development to market.

Discover the impact of expert regulatory consulting on your success. Contact us to explore tailored solutions that propel your projects forward.

Our Regulatory Consulting Services

Our comprehensive regulatory consulting services empower your projects with strategic guidance.
With consultative problem-solving skills and an experienced team, we ensure that every step of your regulatory journey meets the highest standards of precision and professionalism.

Regulatory Strategy Development

Our regulatory experts are equipped to handle every regulatory facet of your drug development program. This encompasses crafting global regulatory strategies, representing regulatory concerns within product development teams, managing IND/CTA submissions and upkeep, providing comprehensive support for marketing authorization, and facilitating interactions with Regulatory Agencies.

We provide strategic regulatory planning and advice tailored to your project’s unique challenges and opportunities. Moreover, we emphasize the importance of risk management and mitigation strategies. Identifying potential risks early and addressing them proactively is key to maintaining your project’s momentum toward its goals.

For the evolving global regulatory landscape, we utilize our network of non-US regulatory affairs specialists to provide strategic consulting from a non-US perspective and handle your ex-US regulatory operations and submissions.

Our regulatory services include:

Global Regulatory Strategy across Product Lifespan
US Authorized Representative (USAR)
Regulatory Gap Assessments and Risk Mitigation Strategies
IND/CTA And NDA/BLA/MAA Strategy, Authoring and Review
Labeling Strategy and Target Product Profiles
Pediatric Development Plans
Regulatory Strategic Product Roadmaps, Including Clinical Trial Country Selection Strategies and Accelerated Strategies
Accelerated Drug Development Strategies (e.g., Orphan Drug, Fast Track, Breakthrough Therapy, PRIME)
Global Regulatory Agency interactions include:
  • Briefing document coordination and preparation
  • Preparation and coaching of your team for the meeting
  • Sponsor representation at meetings
  • Meeting logistic support
  • Meeting follow-up, including analysis, meeting minutes, and dispute resolution

Submission and Documentation Support

Compliance with regulatory standards necessitates preparing, reviewing, and submitting high-quality regulatory documents. Our medical writing experts along with our CMC technical writers are adept at handling every aspect of this process, from initial drafting to final submission.

We ensure that your documents are clear, compliant, and complete, facilitating a smooth review process by regulatory bodies. Our team offers specialized assistance with Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and Abbreviated New Drug Applications (ANDA), guiding you through these complex submissions with ease and expertise.

Regulatory CMC

The regulatory CMC landscape is continuously changing, presenting challenges in developing new drugs, therapies, and devices amidst increasing regulatory expectations and the globalization of R&D and manufacturing.

We excel in navigating these complexities, offering strategic and tactical CMC regulatory solutions tailored to each project’s specific scientific and technical challenges. Our regulatory expertise extends to managing critical quality issues and change management, facilitating regulatory agency meetings, and ensuring the successful clinical development and timely approval of new drugs.

With professionals from the pharma industry and the FDA, Syner-G is adept at designing phase-appropriate and product-specific CMC strategies critical for expedited drug development.

Regulatory Compliance and Liaison

Staying current with regulatory requirements and guidelines is paramount in the biopharmaceutical industry. Our regulatory compliance and liaison services are designed to keep you ahead of the curve, ensuring your projects remain compliant at every stage.

We also serve as a vital link between you and regulatory bodies, acting as your representative to facilitate effective communication and expedite the resolution of any queries or concerns. This proactive approach ensures that your projects proceed without unnecessary delays, maintaining a clear path to success.

Our Legacy of Expertise

In the dynamic field of biopharmaceuticals, where innovation meets stringent regulatory oversight, choosing the right partner for regulatory consulting can significantly impact the success and speed of bringing new therapies and drugs to market. Syner-G BioPharma stands out as a leader in this essential service area. We combine deep regulatory knowledge, a proven track record, and a strategic approach to complex regulatory environments. Our commitment to excellence, paired with a client-focused ethos, makes us the preferred choice for companies seeking to overcome regulatory hurdles and achieve their market goals efficiently.

Experience Since 2007

The cornerstone of our regulatory consulting success lies in our unparalleled industry expertise. Our team consists of seasoned professionals with a profound understanding of global regulatory requirements, essential for developing and commercializing drugs internationally.

This expertise guarantees your projects comply with current standards and are strategically prepared to meet the global market’s demands. Our experts have a proven track record of facilitating successful regulatory submissions, a testament to our strategic planning, thorough documentation, and effective communication with regulatory bodies.
Opting for Syner-G BioPharma as your regulatory consulting partner guarantees access to a team that is familiar with the regulatory environment and has a history of guiding projects to fruition.

Our extensive experience becomes your strategic advantage, allowing us to jointly tackle the intricacies of drug development and registration and paving a smoother route to market approval and commercial success.

Engage our Regulatory Consulting Knowledge

Choosing us as a reliable partner for your regulatory consulting needs means placing your trust in a team at the forefront of regulatory excellence. With our extensive expertise in navigating the complex regulatory landscape, we make sure your biopharmaceutical projects are not just compliant but strategically positioned for global success.

Don’t let regulatory hurdles slow your progress. Contact us today and take the first step towards a seamless journey to market approval and beyond.

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