Syner G Pharma Consulting
Syner-G BioPharma Group is dedicated to advancing scientific innovation and improving patient outcomes through expert guidance at every stage of drug development. They provide comprehensive services including pharmaceutical development, regulatory strategy and submissions, functional outsourcing, medical writing, and quality and compliance, supported by program management and submission support. Their integrated approach helps clients navigate developmental challenges and regulatory complexities to ensure timely, high-quality submissions.
Industries
Nr. of Employees
medium (51-250)
Syner G Pharma Consulting
100 Pennsylvania Avenue, Suite 310, Framingham, MA 01701
Services
Integrated CMC services including drug substance and drug product development, stability strategy, process development and phase-appropriate CMC planning from pre-IND to post-approval.
End-to-end regulatory strategy, submission preparation and agency interaction support for INDs, NDAs, BLAs and global filings, including expedited pathway planning (Fast-Track, Breakthrough, RTOR).
Provision of outsourced or embedded teams (regulatory, CMC, quality) to act as extensions of client teams for development and post-approval programs.
Medical and regulatory writing services including clinical study reports, integrated summaries, Module 2 documents, briefing packages, and electronic publishing to submission-ready formats.
QMS design and implementation, control documentation, quality assurance support, audit readiness, and remediation plans to achieve and maintain GxP compliance.
Comprehensive, risk-based audits and follow-up programs covering manufacturing, laboratory, clinical trial conduct and distribution practices.
Integrated CMC services including drug substance and drug product development, stability strategy, process development and phase-appropriate CMC planning from pre-IND to post-approval.
End-to-end regulatory strategy, submission preparation and agency interaction support for INDs, NDAs, BLAs and global filings, including expedited pathway planning (Fast-Track, Breakthrough, RTOR).
Provision of outsourced or embedded teams (regulatory, CMC, quality) to act as extensions of client teams for development and post-approval programs.
Medical and regulatory writing services including clinical study reports, integrated summaries, Module 2 documents, briefing packages, and electronic publishing to submission-ready formats.
QMS design and implementation, control documentation, quality assurance support, audit readiness, and remediation plans to achieve and maintain GxP compliance.
Comprehensive, risk-based audits and follow-up programs covering manufacturing, laboratory, clinical trial conduct and distribution practices.
Expertise Areas
- CMC development and strategy
- Regulatory strategy and global submissions (IND/NDA/BLA/CTA)
- Functional outsourcing and embedded regulatory staffing
- Regulatory medical writing and e-publishing
Key Technologies
- cGMP manufacturing
- HPLC purification
- Lyophilization
- Sterile fill-finish
News & Updates
Analysis of how unpredictability in tariffs affects biotech supply chains, emphasizing the importance of consistency in drug development.
A case study of how Syner-G supported a medicinal chemist in scaling up a drug candidate to IND submission within 15 months.
Discussion on the evolution of analytical development frameworks under ICH Q14, guiding pharmaceutical and biotech sectors.
Strategies for effective laboratory relocation, emphasizing people, process, and technology.
Guidance on selecting appropriate systems for life science organizations, focusing on clear objectives, stakeholder engagement, and thorough research.
Analysis of how ongoing U.S.-China trade tensions affect the supply chains for investigational drugs.
Analysis of how unpredictability in tariffs affects biotech supply chains, emphasizing the importance of consistency in drug development.
A case study of how Syner-G supported a medicinal chemist in scaling up a drug candidate to IND submission within 15 months.
Discussion on the evolution of analytical development frameworks under ICH Q14, guiding pharmaceutical and biotech sectors.
Strategies for effective laboratory relocation, emphasizing people, process, and technology.
Guidance on selecting appropriate systems for life science organizations, focusing on clear objectives, stakeholder engagement, and thorough research.
Analysis of how ongoing U.S.-China trade tensions affect the supply chains for investigational drugs.