Contact Us

Global Biopharma Excellence

Our India-based team, comprising PhDs, MBAs, and M.Pharm and MS Chemistry professionals, brings over 200 years of collective industry experience to your projects. Specialized in Drug Development, Chemical Development, life sciences, ARD, QC, QA, CMC-RA, and Manufacturing Life-cycle Management, our experts are adept at navigating complex quality and regulatory landscapes, ensuring your projects achieve global compliance and excellence.

OUR IMPACT

Executed 7 “person-in-plant” projects, with more underway, demonstrating our hands-on approach to ensuring excellence and compliance for our clients.

Offer comprehensive services, including technical support, QA, audit assistance, compliance management, and detailed documentation, tailored to meet the stringent requirements of the Biopharma sector.

Value-Added Services

Selecting the right Contract Development and Manufacturing Organization (CDMO) is pivotal to the success of our pharmaceutical development efforts. At Syner-G, our strategic approach ensures that each CDMO aligns perfectly with both CMC standards and broader corporate objectives, embodying our commitment to quality, reliability, and scalability. This meticulous vetting process not only enhances project integration and execution but also optimizes the efficiency and success of the entire development pipeline.

Our Services Include

Expert coaching for SMEs to navigate FDA audits confidently. Comprehensive support for audit preparations, closures, and follow-up.

Extensive training in CMC RA, Quality, and Compliance Management.

Person-In -Plant Assistance in Process Chemistry, QBD, DoE, GMP scale-up, and validations for small molecules (DS, DP) and biologics.

Vendor Management (GMP, GCP and GLP Vendor Audits), Supply chain/Logistics Management

Due diligence, vendor qualification, facility capability assessment, quality culture assessments, EHS audits, implementation of QMS and PAIs

Managed outsourcing – managing end to end supply chain, logistics, manufacturing, quality, and release of products for our clients for their projects in India. 

Monitoring of Manufacturing, Trouble shooting, Investigations, Batch releases, Spot Checks, Inspections, Mock Audits, Trainings, Implementation of policies, Data integrity, OOS investigations, deviations, CAPAs.

Case Studies