Our Services

Our Services

Consultancy Services

We offer a range of consultancy services to the pharmaceutical companies including but not limited to

  • Designing, planning & execution of facility
  • Designing, planning & execution of laboratory
  • Forensic Audits of Analytical and Process 
  • Quality System Assessment (FDA 6 system assessment) and remediation
  • Vendor Auditing and Qualifications
  • GLP System and Processes Improvement
  • Stability Program Improvement
  • Manufacturing Processes Improvement
  • Technology Transfer (Process & Analytical)
  • GMP System & Customer, Regulatory Audits 
  • Regulatory submissions & support in responding to regulatory inspection

GMP & GLP Solutions

We are pleased to provide GMP solutions to the pharmaceutical industry in areas related to APIs and Drug Products

Our experienced team of experts and technical associates are geared to respond to the industry’s practical problems encountered on a regular basis. Where others may not have an answer to your problems, we guarantee to provide you with a resolutions.

Since our experts come from within the industry with loads of hands-on experience, we know where people might go wrong and consequently, we understand the root cause.

The key areas in which intelligent and quick solutions can be provided for problems faced by companies include:

  • Laboratory/facility Designing
  • GMP Compliance
  • Regulatory Compliance
  • Regulatory responses
  • HVAC systems
  • Water systems
  • Other Utility systems
  • Qualifications & Validations
  • Documentation
  • Microbiology
  • Computerised Systems
  • Laboratory related

Validation Services

We offer the following validation services to the pharmaceutical companies

  • Temperature/RH mapping of rooms 
  • Transport Validation
  • Stability Chambers-Qualifications 
  • Process Validations
  • Instruments/Equipment Qualifications
  •  Packaging Validations
  • Analytical Method Validations 
  • Container – Closure Integrity
  • Microbiology related Validations 
  • Computer System Validations

Audit & Compliance

We offer well organised “Audit & Compliance Services” for the manufacturing facilities, GMP systems, Laboratory systems, Production related systems and R&D laboratories

Our versatile experts with decades of experience on auditing/inspection requirements of regulatory and GMPs provide you with the best compliance audits/findings, GAP analysis and ready-to use solutions. Using our auditing services, the companies can enhance their compliance standards and succeed during regulatory inspections

During the audits conducted by us, we offer you recommendations and solutions that enable you to overcome the deviations in a very systematic manner.

We conduct audit/assessment in various pharmaceutical companies in the following areas:

  • Due Diligence Audit
  • GMP Systems’ Audit
  • Documentation Audit
  • Failure Investigation Audit
  • Vendor and Supplier Audit
  • Facility Audit (Manufacturing – R&D – Laboratories – Utilities)

Training & Internship Services

The aim of this program is to bridge the gap between industry accepted standards and student expertise.

We hold an esteem position in offering several training programs in the form of online as well as offline across different cities of India. These programs are created for professionals from different fields of Pharmaceuticals companies.

We specialise in “In-house training programs” for the companies who are
interested in customised programs to be organised for a set of people within their companies.

We also conduct special certified training programs for fresh graduates and postgraduates aspiring to enter the Pharma industries. These courses provide them with an excellent opportunity to smoothly transition into the industries

Regulatory Services & Documentation Support

We specialise in the “preparation of dossiers, preparation of responses to audit queries and observation etc”. We have expertise on

  • SOP Preparation and Amendment
  • Site Master Files ( SMF )
  • Validation Master Plan
  • Quality Manual
  • Training Manual
  • Safety Manual
  • WHO-TRS Approval
  • ROW Filing and COPPs Approval.
  • Various Statements preparing and submission