CMC Landscape

What is CMC Landscape?

Regulatory and quality compliance are statutory requirements under the US FD&C Act and Federal Regulations. It is also true with global health authorities. Compliance requirements apply to both investigational and marketed products. In the maze of ever changing pharmaceutical industry paradigms and regulatory environment, proper compliance can be challenging and complicated. However, such compliance achieved by conscious and diligent efforts can be a strategic and competitive advantage for Biotech and Pharma 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 in The CMC World

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

  • Regulatory Starting Materials
  • 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

Our Approach

At Syner-G, we strongly believe that sound science and technology are fundamental building blocks for the optimal design, successful development and compliant maintenance of the quality pharmaceutical products. We also understand that it is not practically feasible for early to mid-stage Biotech/Pharma companies to have all the necessary CMC resources to steer through 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.

We are ready to be a seamless extension of your organization to fill your CMC needs and offer customized CMC solutions to expedite the 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 CMC Regulatory Affairs, Pharmaceutical Development, and QA/cGMP Compliance (CMC-360 ) with a flexible and adaptive models of talent utilization and pricing.

We also offer CMC regulatory services and support to large pharma companies to fulfil their requirements in the strategic or tactical areas, as needed

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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