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Consulting

Pharmaceutical industry faces a lot of challenges as we are dealing with patients’ safety. In order to cope up with day to day challenges, we need to evolve in every aspect.

We provide an at par consulting service to match with the existing regulatory requirements and modernize the operations.

We understand the requirements of our customers and conceptualize those challenges to detailed solutions. As part of our consulting solutions, we have following different setup and support services.

 

Setup services

GMP upgradation

Considered by wide range of suppliers including API & excipient manufacturers and Formulation specialists. Details are as follows.

 

GMP Consultation

  • Tailored Audits to client’s unique requirements.
  • Manufacturing process review to ensure the most efficient process to increase productivity.
  • Security Assessment and reassurance about minimum risks of deficiencies.
  • Helping with very fresh approaches, SOPs, software, employee motivation techniques.
  • Investigation of failure: Issue specific investigation with simultaneous assessment approach
  • Defining and Setting up procedures for Data Integrity: keeps check on integrity failure
  • Computer System Validation, IT Setup audits and regulatory compliance

QMS Review

  • Helped many API plants and manufacturing facilities on system improvement by guiding on systems and infrastructure.
  • Restructuring the QMS / Quality Assurance System.
  • Increasing the QMS efficiency
  • Redesigning the QMS SOPs and Process life cycle management

GCP upgradation (CRO/Site)

Considered by Clinical Research organizations and / or SMO-hospital sites. Details are as follows.

 

GCP Consultation

  • Improving the existing systems by guiding on CRO infrastructure and system
  • Helping with very fresh approaches, SOPs, software, employee motivation techniques.
  • Identification of Duplication/Over Compliance: To reduce the over documentation and avoiding data duplication
  • Investigation of failure: Issue specific investigation with simultaneous assessment approach for Clinical, Bioanalytical and PK-Stat processes-data
  • Defining and Setting up procedures for Data Integrity: keeps check on integrity failure
  • Computer System Validation, IT Setup audits and regulatory compliance

QMS review

  • Restructuring the QMS / Quality Assurance System.
  • Increasing the QMS efficiency
  • Redesigning the QMS SOPs and Process life cycle manageme

CRO Set-up

  • Location
  • Floor diagrams
  • Systems and Infrastructure Designing
  • Procurement
  • Recruitment and Training
  • First study execution

  • Improvement through retrofitting modification in existing CROs / Bio-centers

Plant Set-Up and Due Diligence

  • Pharmaceutical Plant Designing is a skilled job. Wrong design leads us to the failure/rework.
  • All kinds of international Audit/inspection success depend on Plant Design.
  • Our GMP expert team handles all kind of Turnkey Pharmaceutical/Biotech Projects and meets the designing demands.
  • Our knowledge on building constraints as well as regulatory requirements helps us to successfully establish GMP-compliant manufacturing facilities.

  • We provide operational due diligence auditing services which is a crucial activity in case of mergers and acquisitions.

Software support

GxP Training

Licensing

We give assistance to pharmaceutical companies in defining its in-/out-licensing strategy and maximizing the value of their products and technologies. In and out-licensing activities are excellent opportunities for companies that want to quickly expand their portfolio or gain return on investment in a relatively short period. Through our strategic positioning, we can promote and market the products in respective territories. We also assist to companies to register their dossiers in all indicated areas or we may ensure any dossier based on customer´s requirements. Below are the segments.

Licensing

  • Dossier out license of a product which follow 505(B) (2) regulatory pathway.
  • Dossier out license of an ANDA.

Product Development

  • From product search, portfolio development to dossier compilation, contract manufacturing, registration and marketing of the product