Regulatory Support:

  • Preparation & Submission of Drug Master Files as per the ICH CTD guidelines for US, Europe, Korea, Japan in addition to other Technical Documents.
  • Evaluation and handling of Post DMF changes.
  • Handling of Regulatory and customer Audits.

cGMP Consulting & Training:

  We provide the following services:

  • Gap Analysis.
  • Gap Analysis and remedial action Plans
  • Auditing
  • cGMP Compliances, Schedule "M" implementation
  • Implementation of Quality Management System
  • Establishment of cGMP, GLP & GWP
  • Establishment of ISO & HACCP standards with certification
  • Identification of Validation requirements,
  • Preparation of Master Validation Plan
  • Preparation of Validation protocols and execution of validations.
  • cGMP Trainings
  • Support to USFDA, WHO GMP, FDA, ISO, OHSAS certifications.
  • Handling of Regulatory enquiries.

Contract Manufacturing:

We provide manufacturing support to our customers on Principal to principle basis. We have contract with the cGMP compliant Manufacturing units in Excise free zones for manufacturing of our products. The products are manufactured under technical guidance of Havisa Healthcare and Quality is ensured by well experienced Quality Assurance personnel at Havisa Healthcare.

RM Trading:

At Havisa we also offer Raw Materials from good Manufacturers and at a competitive rates. Quality is of utmost importance to us. We also deal in DMF grade material. We deal in Active Pharmaceuticals Ingredients (APIs), Excipients & Vitamins. For Business enquiries, refer 'Contact us'.