CMC/Pharmaceutical Development

Providing CMC Consultation

Syner-G provides CMC consultation to address drug substance (DS) and drug product (DP) development challenges.  Closely working with the clients, we enable CMC decisions for important topics such as the selection of API starting materials, defining CPPs and CQAs, control strategies for genotoxic impurities, DS/DP specifications, stability protocols, QbD approaches to product/process design etc.  We excel in providing these services for early to mid-stage biotech and pharma companies who use a virtual drug development model.

So, allow us  to be your virtual CMC development organization, handling the strategic planning and tactical oversight needed to ensure efficient and timely CMC pharmaceutical development . We offer scientific and technical consultation along with project management support for process and product development, analytical method development and selection and management of contract development, manufacturing and testing sites for drug substances and drug products. Our expert consultants have real world experience in applying the state-of-the-art scientific and technological approaches and quality standards to develop the right quality target product profile (QTPP) for your drug and design the product and process using Quality by Design (QbD) principles.

Our customized solutions include:

  • Leading the drug substance synthesis and chemical and process development
  • Selection of appropriate API starting material(s) and supplier(s)
  • Oversight of preformulation/formulation activities
  • Development of control strategy for genotoxic impurities
  • Dissolution testing/Bioequivalence
  • Identification, selection and management of contract manufacturing and quality testing sites (CMO/CRO) for clinical and commercial drug substance/drug product
  • Oversight of Technology transfer/Method transfer
  • CMC Project management support for outsourced activities
  • CMC Technical due diligence support for in-license/out-license
  • Technical review of routine cGMP documentation, e.g. batch records, stability protocols, validation reports etc.
  • Study-design and data-analysis to characterize critical manufacturing process parameters and integration into product specifications and overall control strategy
  • Criticality/risk analysis and development of risk mitigation strategies to minimize the impact of unexpected results on project timelines
Our Focus:

At Syner-G Pharma Consulting, Chemistry, Manufacturing and Controls (CMC) is our sole focus. We offer a complete suite of CMC solutions (CMC-360) in the following three core areas: Regulatory Affairs, Pharmaceutical Development, and QA/cGMP Compliance.

Contact Us:

Syner-G Pharma Consulting, LLC
371 Turnpike Road
2 Park Central Drive, Suite #110
Southborough, MA 01772
(508) 460-9700

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