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Pharmaceutical Services

Pharmaceutical Services

Focusing on promoting innovation & knowledge

Overview

Seemax Biotech also provide the consultancy services and pleased to inform that now Seemax Biotech is in position to provide consultancy services to small, medium and large pharmaceutical enterprises for all their needs in setting up a Green Grass Projects and also the Establishment of systems, Training and Gap Assessments.

Seemax Biotech specialize in GMP Compliance, Validation, Continuous improvement Consulting, DMF/Dossier preparation, WHO GMP Certification, Handle Legal issues related to FDA and Training.

We provide Consulting, training and technical support are just some of the integrated services of Seemax Biotech which provides to enable its clients to meet all international GMP regulatory standards.

Service Areas

Service Areas

GMP Designing of Manufacturing Facilities

  • • Conceptual designing (layout) of Plant.
  • • Basic and detailed engineering.
  • • Process, materials, finished goods & personnel flow.
  • • Mechanical & electrical (M&E) requirements.
  • • Provide input for suitable materials of construction (MOC).
  • • Designing of water system like DM, DI, RO or WFI, inclusive of required piping system.
  • • Providing assistance in selection and sourcing of required instruments and equipments.
  • • Designing of suitable utility system e.g. HVAC, compressed air, steam, de-dusting, AHU, AHUs with BIBO System.

Quality Management System Development

  • • Quality Systems development.
  • • Mapping of existing systems and transition assistance to new Best Practice Models.
  • • Customization of Quality Systems for required Quality System Element; QSE.
  • • Change Control.
  • • Deviations/Investigations/CAPA Systems.

Regulatory Affairs

  • • Total Quality Management of Bulk Drugs & Formulations including ISO Accreditation.
  • • Regulatory Affairs.
  • • Upgrading the systems, procedures & Documentation to meet the Requirement of USFDA, MHRA-UK, TGA and other regulatory requirements.
  • • Preparation of Inspection by External Bodies.
  • • Preparation, review and submission of DMF’s (CTD and ECTD format), Dossiers, and product Dossiers for registering in various Countries.

Training

  • • Development of Training Programs.
  • • Development of Training Documentation.
  • • Specialized Training Courses for cGMP & cGLP.
  • • Group Training Sessions.
  • • Workshops.

Quality Services

  • • QA Management Support.
  • • Compliance Assessments related to cGMP, cGLP and cGSP Mock FDA and EU Audits.
  • • Internal & External Quality Audits.
  • • PAI (Pre-approval Inspection) Audits.
  • • Third Party Audits of Contractors, Suppliers, Raw Material/Intermediate Sources.
  • • Annual Product Review.
  • • Quality Agreements.

Document Systems

  • • Design of Systems and Procedures.
  • • Document Design & Preparation.
  • • Batch Manufacturing Records (BMR’s).
  • • Standard Operating Procedures (SOP’s)
  • • Policy Documents.
  • • Validation Master Plans (VMP’s).
  • • Validation Documents.

Out Sourcing

List of Products
API
  • 1. Sterile and non sterile.
  • 2. Pellets.
Dosage Form
  • 1. Injectables.
  • 2. Oral Solid.
  • 3. Lyophillized.