Regulatory Compliance

OUR SOLUTIONS
  • Regulatory Compliance framework and process design
  • Compliance Training
  • Behaviour based safety training
Regulatory Compliance
For the operating environment of the pharmaceutical and life sciences industry, compliance with regulatory and safety guidelines is a critical parameter. The costs of non-compliance with these guidelines often runs into millions of dollars and can also result in serious warnings and plant closures by the regulatory authorities. It is, therefore, essential that the design and implementation of the compliance framework and internalization of these through rigorous training programs be done in a manner that is systematic and tangible.

Our dedicated Life Sciences Practice provides comprehensive consulting and training solutions in the areas of compliance frameworks – GMP, GCP and GLP as well as training solutions both classroom and online.

Report Writing

OUR SOLUTIONS
  • Technical document writing skills for Manufacturing
  • Technical document writing skills for R&D
  • Case study driven and application oriented workshops
Report writing
In the highly regulated environment of the pharmaceutical industry, documentation plays a key role from a compliance standpoint. Indeed, only written documentation is considered as evidence of an activity, and it is, therefore, critical that documents are written in language that is unambiguous.

Our training programs on document writing are both comprehensive and application oriented – these are different from typical Good Documentation Practice trainings which concentrate on the ‘What’ rather than the ‘How’. The focus of these programs are to enhance technical writing skills from a structure, content, logic, flow and integration perspective. The sessions are structured for around 50 hours of classroom training with a mix of both conceptual knowledge and hands-on practice using case examples customized with the organization’s inputs.

Project Management Advisory

OUR SOLUTIONS
  • Building project management capabilities
  • Process development and workflow systems
  • Project Management training programs
Project Management Advisory
For the pharmaceutical and life sciences industry where the environment is primarily project driven, it is essential to build sustainable capabilities for managing and delivering projects on time, within budget and in scope. While the industry has adopted several principles of project management, the maturity of project management in this industry is still evolving, and the understanding of how to apply project management tools and techniques in an integrated manner is still nascent.

Our Life Sciences Practice through its domain experts specialises in diagnosing maturity baselines and establishing roadmaps for maturity in project management. The solution focuses on developing best practice processes and workflow systems customized to the relevant business models along with enhancing competencies for the project managers through multiple interventions.