Regulatory Services

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Lyne’s Regulatory Group maintains compliance systems that meet or exceed FDA regulations

With more than 35 years of experience in manufacturing oral liquid pharmaceuticals and other dosage forms, Lyne has the technical expertise and experience to ensure that projects are completed on time and on budget. We have a proven track record in successful FDA pre-approval and post-validation inspections for both new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Our staff’s complete understanding and working knowledge of the FDA’s scale-up and Post-Approval Changes Guidelines ensures efficient product transfers every time. Various company registration and services are supported by our regulatory department.

Our in-house quality assurance group is cognizant of the many regulatory and compendial guidelines promulgated by the FDA and maintains compliance systems with goals to meet or exceed those regulatory requirements. We have a history of working in conjunction with our partner firms to successfully deliver properly executed IND, NDA and ANDA submissions. Lyne has the experience and qualifications to meet all regulatory requirements of product development and manufacturing including technology transfer, pilot and engineering batches, commercial services validation and commercial production runs.  Lyne has a successful track record with FDA pre-approval and post-validation inspections for new and abbreviated drug applications, CMC sections, clinical supplies for late stage Phase III studies, cGMP compliance and regulatory services.

Our Credentials

  • FDA Registered
  • EPA Registered
  • DEA licensed
  • Inspections
    • Pre-Approval (FDA)
    • Post-Validation (FDA)
    • External Client Audits
  • Submissions
    • CMC section of ANDAs and NDAs
    • Post-submission activities
  • cGMP Compliance Program
  • Document Control Program

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