Services
Our Services
Your biopharmaceutical partner in CMC, Regulatory and Quality

CMC
Technical expertise in process development, Process validation, deviation investigations and reports, manufacturing, analytical development, in-process testing/control strategy, quality control, technology transfers, comparability assessments and reports.

Technical/Regulatory Writing
Regulatory support in drafting/reviewing briefing books to support INTERACT and Pre-IND meetings and IND, IND amendments and BLA submissions. Technical writing support for development reports, SOPs, validation protocols and reports, BPRs, investigation reports, manuscripts and white papers.

Regulatory
Non-clinical and CMC regulatory strategy and writing support for FDA, EMA and Health Canada interactions.

Quality
Strategize, set up and operationalize QMS for early phase companies, perform audits, remediation support, draft policies and procedures, and risk assessments.

Vendor Management
Support CDMO/CTO/CRO assessment and selection through RFP process, technology transfers and project management and interactions.

Market Research/Due Diligence
Assess technology, platform and/or companies against current competitive landscape and for individualized customer needs.

Supply Chain/Procurement
Perform supply chain risk assessment to evaluate risk due to single sourcing, supply chain back order, shipping/import/logistical challenges and provide optionality for alternate procurement strategies.
Our Services
Your biopharmaceutical partner in CMC, Regulatory and Quality

CMC
Direct CMC experience from Big Pharma and start-up biotech environments with cross-functional expertise in quality, regulatory, manufacturing, analytics, quality control and stability and a deep appreciation for the interplay among the various functions

Analytical Life Cycle Management
Conceptualize, develop and validate release tests and in-process QC tests for vaccines, viral vector therapies and in vitro devices.

Molecular Biology
Deep expertise in molecular technologies in support of vaccines, therapeutics and devices. qPCR, gel based techniques, arrays, cloning, nucleic acid and protein extractions

High-Throughput Sequencing
Next-generation sequencing and its use in GMP environments to support genome sequencing and variant analysis, adventitious agent detection, and mutanome mapping

Immunology
Antibody isolation and purification, ELISA, ELISPOT, Western blotting, immunofluorescence assays, multi-pronged serology assays

Bioanalytics
Design, develop and validate assays in biological matrices to support
pre-clinical toxicokinetic or biomarker concentration studies, with supporting
dose-formulation verification and stability studies

Sterility/Bioburden Testing
Rapid microbial methods (RMMs), direct inoculation/membrane
filtration tests, B/F Testing, bioburden for medical devices, pharmaceuticals and raw material

Biostatistics
Statistical analysis to justify setting product release specifications
and stability excursion limits

Program Management
Program management of complex biological programs and medical devices from proof-of-concept to commercialization.
Third-party vendor management for outsourced work

Technical/Scientific Writing
• Development reports, SOPs, validation protocols and reports
• Batch production records and work instructions
•Overarching quality management documents
•Regulatory writing (IND, CTA) and FDA responses
• Investigation reports
•Manuscripts and white papers

Regulatory
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Quality
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Vendor Management
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Technical Support
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Market Research/Due Diligence
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Supply Chain/Procurement
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