VALUE ADDED SERVICES
SOURCING
We also help in sourcing for ACTIVE PHARMACEUTICAL INGREDIANTS (API), Bulk drugs & Contract Manufacturer for Formulation.
GMP AUDITOR
We also conduct GMP Audits to monitor the compliance of GMP for Quality endeavors and Investigation for Quality failure.
TRAINING
We provide total training for GMP / GLP/GWP/GEP/ VALIDATION /STABILITY/ DOCUMENTATIONS.
We also provide Guideline for preparation of CTD / DMF / ANDA Documents.
FACILITY AUDIT CONSULTANCY
We also offer Facility Audit Consultancy which is important for clients who are planning to purchase an existing pharma unit. Our primary audit check points covered are as below:
- Review of the fair value of the plant ,building & machinery.
- Review of existing layout and setup
- Review of existing capacity of machinery with residual capacity and life
- Review Document of regulatory certification.
- Review of the AHU systems
- Review of the FDA approved plan layout.
- Review of the license & product permission.
Support Services
Project Management
Inspection
- Plant Equipments.
- Storage tanks & vessels.
- Pressure vessels & columns.
- Heat exchanger.
- Pumps, fans , blowers.
- Packaged unit.
- Electrical item & equipments
Production Assistance
- Preparation of vendor’s list.
- Obtain technical datasheets and quotes.
- for equipment and packaged items.
- Issue tenders documents.
- Tender analysis and recommendation.
- Assistance during negotiation.
- Expediting supplies and inspections.
Construction Supervision
- Site management & client co-ordination
- Co-ordination with suppliers and contractor.s.
- Quality control.
- Co-ordination with design teams.
- On-site inspections.
- Safety and hygiene.
- Shut-down planning (in case of expansion/modification of existing plants).
- Trial-runs and commissioning assistance.
- Completion certification and as-built drawings approval.
