The CMC Landscape

CMC is Mission Critical

Regulatory and quality compliance are statutory requirements under the US Food, Drug, & Cosmetic Act and other federal regulations, and similar regulations apply outside the US with other global health authorities. Compliance requirements apply to both investigational and marketed products. In the maze of ever-changing pharmaceutical industry paradigms and the dynamic regulatory environment, proper compliance can be challenging and complicated. When compliance is achieved through conscious and diligent efforts, it can be a strategic and competitive advantage for biopharma companies.

Current Paradigms

Industry Challenges
  • Challenges in drug candidates (druggability)
  • Challenging diseases and patient population
  • Timely adoption of modern science and technologies
  • Ongoing changes in global regulations
  • Mergers and acquisitions
  • Patent cliff/competition
  • Expedited development
  • Globalization/outsourcing
  • Lean/cost effective operations
Regulatory Environment
  • Constant changes triggered by advancement of science, medicine, and technology
  • Promotes adoption of modern science/technology
  • Promotes risk-based approaches but yet conservative
  • Enhanced focus on pediatrics and geriatrics
  • Lack of global harmonization
  • Increasing compliance expectations from global agencies
  • Increasing regulations due to fast-growing pharma supply chain globalization and outsourcing
  • Concerns due to economics-driven fraudulent acts such as adulteration and counterfeits

Current Hot Topics

Syner-G provides support to manage any of these CMC challenges

  • Regulatory Starting Materials (RSMs)
  • Genotoxic impurities
  • Quality by Design (QbD)
  • Defining CQAs and CPPs
  • Risk analysis and risk management
  • Control strategy/design space
  • Dissolution and bioequivalence
  • Continuous manufacturing
  • Drug-device combination products
  • Immunogenicity
  • Comparability protocols for cell-line change
  • Affordable Care Act and biosimilars
  • Demonstrating biosimilarity
  • Breakthrough products
  • Process validation and continuous process verification
  • Post-approval comparability protocols/change-management plans
  • Process analytical technologies
  • Real-time release testing
  • Chemometrics and knowledge management

CMC is Mission Critical

We strongly believe that sound science and technology are fundamental building blocks for the optimal design, successful development, and compliant maintenance of quality biopharma products. We also understand that it is not practically feasible for early- to mid-stage companies to have all the necessary CMC resources that are required to navigate the web of drug development challenges. Therefore, we have assembled a strong team of CMC professionals with extensive experience in successful development, regulatory filing/approval, commercialization, and life-cycle management of pharmaceutical products.

Syner-G is built to function as a seamless extension of your organization, filling your CMC needs with customized CMC solutions to expedite your drug development with maximum flexibility and efficiency without compromising quality and patient safety. We have designed our organization with three core business units that offer a full suite of CMC services in the areas of Regulatory Affairs, Technical Development, and Quality Compliance. This integrated approach, which we call CMC 360™, is available to you with flexible and adaptive models of talent utilization and pricing.

For large, multinational pharmaceutical innovator companies, we provide CMC regulatory services and support that fulfil their requirements in strategic or tactical areas, as needed.


100 Pennsylvania Avenue, Suite 310
Framingham, MA 01701

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