1. Cgmp Consulting:

a. Manufacturing Facility:

     •  Assessment of ‘manufacturing facilities' and ‘Quality System' with reference to the expectations of international regulatory agencies         like US FDA, MHRA, U.K (formerly MCA), TGA (Australia) etc. and prepare ‘Gap Analysis' report.
     •  Design reviews of new facilities for the production of APIs and sterile/non-sterile drug products.
     •  Advising on the refurbishment of manufacturing facilities.
     •  Advising on the design of utilities (e.g. Air and Water Systems).

b. Review of Quality System Documentation:

Advise on structure and adequacy of following type of quality documents.

     •  Quality system procedures.
     •  Standard operating procedures.
     •  Specifications and test methods.
     •  Raw data and other record formats.

c. Material Flow Clearance system:

     Review manufacturing flow chart and suggest suitable material flow and clearance system throughout the supply chain beginning from raw material supplier upto customer.

     Design recording system to provide traceability for future evaluations and investigations.

d. Validation Programs:

     •  Preparation of ‘Master Validation Programs' and reviewing progress.
     •  Review Protocols and assist implementation of Validation Programs for following critical activities.

          •   Analytical methods
          •   Cleaning methods
          •   Key production operations
          •   Qualification of key equipment's
          •   Utilities like water and AHU system
          •   Manufacturing processes

e. Impurity Profiling:

     •  Advise on identifying potential impurities in the products per ICH requirements
     •  Degradation studies and shelf life determination.
     •  Evaluation of analytical methods for impurity determination

f. GMP Audits:

     •  Periodic audits to verify compliance to defined systems.
     •  Assist implementing routine GMP inspections and organizing periodic self-audit program.
     •  Assessment of GMP status in preparation for regulatory audits.
     •  Participation in regulatory audits.

2. DRUG MASTER FILES

     •  Review drafts of Drug Master Files (CTD format) against ICH requirements.
     •  Advise on generation and presentation of relevant data.
     •  Assist preparation of suitable replies to queries from regulatory agencies and customer.

3. PHARMACEUTICALS VENDER DEVELOPMENT

Assist pharmaceutical organisations in following areas.

     •  Short list potential contract manufacturers based on clients needs.
     •  Assessment of vendor's quality system and contract manufacturing capability.
     •  Assist vendor to implement cGMP systems meeting international standards.
     •  Monitor quality system of the ‘Vender' through periodic ‘Quality audits' in line with client's expectations.

4. PHARMACEUTICAL ENGINEERING

     We had close association with reputed pharmaceutical design engineers in specialised areas to provide turnkey solutions. The design activity includes:


     •  Consultancy Services for chemicals and Pharmaceuticals Projects with Expertise in setting up Plants for manufacture of Bulk Drugs and
        Active Pharmaceutical Ingredients complying to US FDA & GMP Standards.
     •  Safety audits and preparation of safety manuals, Safety Procedures, Fire prevention and fire fighting systems.
     •  Effluent treatment and disposal systems, Air handling and air purification and ventilation systems Pollution prevention and control
        systems.
     •  Design of facilities for API's finished dosage forms (sterile & non-sterile)
     •  Design and fabrication of Air handling units for different classified areas.
     •  Design and commissioning of water systems for use in pharmaceutical processes.

5. CUSTOM SYNTHESIS MANAGEMENT

     •  Identify capable laboratories and co-ordinate following activities towards supplementing drug development activities.
     •  Synthesis of drug intermediates and API's in gram to kilogram quantities.
     •  Process development and contract research.
     •  Pilot plant manufacture.
     •  Synthesis of speciality organic compounds for research and clinical studies.