Concept & 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 understand the requirements of our customers and conceptualize those challenges to detailed solutions.

As part of our concept and consulting solutions, we have different setup and support services. We provide an at par consulting service to match with the existing regulatory requirements and modernize the operations.

Setup services

CRO set up / up skill

  • Greenfield Development of CRO (from identifying the location, floor diagrams, systems and infrastructure designing, procurement, recruitment, training, first study execution)
  • Consultancy period till the newly established CRO clears its first regulatory inspection
  • Improvement through retrofitting modification in existing CROs

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 Project.
  • We have extensive experience in meeting the designing demands of manufacturing facilities for pharmaceutical products.
  • Our knowledge on building constraints as well as regulatory requirements helps us to successfully establish our clients GMP-compliant manufacturing facilities.
  • Due diligence is a crucial activity that should be undertaken when contemplating activities such as mergers and acquisitions. We provide operational due diligence auditing services in pharmaceutical, healthcare and other related industries.

GCP upgradation (CRO/Site)

  • Improving the existing systems by guiding on CRO infrastructure and system
  • Helped many CROs with suggesting some 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

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

GMP upgradation

  • Audits tailored to the unique requirements of our clients.
  • Review every phase of manufacturing process to ensure the most efficient process to increase productivity.
  • Assessment of security and reassurance about minimum risks of deficiencies.
  • Helped many CROs with suggesting some 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

  • 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

Software support

Dossier 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