With more than 30 years of experience in manufacturing oral liquid pharmaceuticals and other dosage forms, Lyne has the technical expertise and experience to ensure that your project is 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.

• FDA Registered

• EPA Registered

• DEA licensed

• ISO 9001 Certification

• 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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