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Global Submission Support

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Syner-G is your comprehensive partner for global regulatory affairs services across all stages of product development and post-approval. Our team is equipped with a wealth of experience and expertise, offering strategic solutions and hands-on guidance to navigate the complex regulatory environment effectively.

As you seek to enter markets around the globe, our Global Submissions Support team specializes in handling the regulatory requirements of diverse regions. We ensure your submissions are aligned with local standards, facilitating a smooth regulatory review process.

Comprehensive Services Include:

Authoring and reviewing components for FDA, Health Canada, MHRA, and EMA
Electronic publishing of global submissions (IND, CTA, NDA, BLA, MAA)
Document management, formatting, and pre-publication services
Project management for IND/CTAs, major IND/IMPD amendments, NDA/BLA/MAA submissions

IND/CTA Submissions & Maintenance

Your Pathway to Clinical Trials:

From the initial Investigational New Drug (IND) application to the Clinical Trial Authorization (CTA), we facilitate every step of your submission process. Our team ensures that your documents are meticulously prepared, reviewed, and maintained to meet the dynamic requirements of regulatory bodies worldwide.

Continuous Regulatory Compliance:

Maintaining your IND/CTA involves a vigilant approach to changing regulations and ongoing data. Syner-G is adept at managing these updates, ensuring your submissions are always current and compliant.

BLA/NDA/MAA Submissions & Maintenance

Accelerating Market Access:

For Biologics License Applications (BLA), New Drug Applications (NDA), and Marketing Authorization Applications (MAA), our team crafts compelling submissions that articulate the value and safety of your product. We navigate the intricacies of each application process to expedite your journey to market.

Post-Approval Mastery:

Post-approval, we stand with you to maintain the lifecycle of your product. With Syner-G, updates, variations, and renewals are handled with precision, supporting your product’s sustained success in the market.

Document and Project Management:

Our team is driven to provide document and project management services for your team, helping to organize your source documents and provide timeline transparency such that the cross-functional teams are coordinated for submission preparation success!

Document Organization:

We are adept at sorting and organizing source documents stored across multiple locations to enable efficient and timely submission authoring. Documents are evaluated as they are sorted, with any gaps or conflicting information identified to prevent delays to submission preparedness.

Project Management:

Our project managers thoughtfully prepare submission timelines both within a function and across functions, ensuring the inter-dependent source documents and Common Technical Document (CTD) sections are available to teams in a timely manner. We also work with teams to develop submission key messages, keep dashboards for reporting to senior management, and provide any additional project management support your team may require during submission development.

CMC Technical Writing and Clinical Regulatory Medical Writing

Expert Documentation Preparation:

Clear, concise, and technically accurate Chemistry, Manufacturing, and Controls (CMC) documentation is crucial. Our CMC technical writing experts bring clarity and compliance to your regulatory documents, ensuring they meet the high standards of global authorities.

Detail-Oriented Approach:

With a keen eye for detail, and working closely with our regulatory strategists, our writers translate complex technical data into comprehensive regulatory documents while ensuring key messages are incorporated to strategically position your data. This meticulous approach minimizes questions from reviewers and expedites approval timelines.

Document Formatting and Templates:

We provide templates and document formatting to make the authoring process easy for the subject matter experts.

Electronic Publishing

Submission Readiness:

In the era of electronic submissions, being technically skilled is a necessity. Our electronic publishing services ensure that your submissions are formatted correctly, validated, and ready for submission to regulatory authorities across the globe.

Seamless Submissions:

Our publishing team stays abreast of the latest electronic submission guidelines, utilizing cutting-edge software to prepare your dossiers in the required eCTD format. This expertise allows for smooth, error-free submissions every time.

At Syner-G

We pride ourselves on our transparent and adaptable approach, fostering trust and building lasting relationships. Our global regulatory affairs department is here to surpass your expectations and drive your success.