Compliance & Training

To us, compliance can be viewed through two lenses, Preventative and Corrective. The preventative approach embraces understanding the complex rules and regulations that govern prescription drug development. Corrective approach addresses non-compliance situations (warning letter, consent decree) that arise when companies do not comply with applicable rules and regulations. The Ayd Group provides support in Preventative Compliance.
This is why we shine when timelines are tight, resources are thin, and quality/compliance cannot be compromised. We help clients meet the challenges of changing regulations, such as the serialization of pharmaceutical products and their supply chains. We help clients address U.S. and global regulatory requirements.

CASE STUDY 

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US Drug Supply Chain Security Act (DSCSA): How Medical Device Manufacturers Must Comply

Preventive Services Include:
Quality Systems & Training Support
  • SOP Writing
  • Provide in-house training on FDA regulatory issues and new policy developments
  • Drug Supply Chain Securities Act (Serialization) compliance
Audits (Quality & Compliance Consulting, cGMP Consulting)
  • cGMP and cGLP facility and cGCP compliance
  • Gap assessments,
  • PAI readiness
  • Commercial readiness

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