- Formulations and Licensing
- Clinical Development – BA/BE studies and Clinical Studies
- Contract Manufacturing
Formulations:
Finding right CDO/CROs for developing the products of your choice
Consulting for In and Out Licensing
Project Planning and Management
Strategic Sourcing – APIs, Excipients and Raw materials
Consulting for Licensing – In and Out
Technical Expertise
Clinical Development:
Finding right Clinical Research Centers for BA/BE studies
Project Feasibility
Project Planning and Execution support
Regulatory Support
Technical Expertise
Contract Manufacturing:
Finding right CMO for site variation projects
Technology transfer projects
OSDs – Tablets and Capsules
Sachets
Pellets and granules
The specialization of INDTEK lies in analysis, management of programs, and strategies for products development with support of Clinical development.
We hold the proficiency and the means to value the effectiveness and safety of the latest and innovative therapies and drugs for a complete plethora of therapeutic indications with complete confidentiality and competence. We aim at adding value to our clientele and thus we focus on excellence and quality.
Feasibility:
BA/BE studies:
Our medical and pharmacology experts works on the literature and feasibility for the target market to conduct the BA/BE study.
Understanding of global regulatory requirements and building the clinical programs accordingly is the key for success.
Project management:
At INDTEK, we hold the faith that efficient leaders holding the wheels in the front seat, is highly crucial for the success of any project. And so, we make sure a group of highly experienced, skilled and trained personnel complete the project management team at INDTEK.
The basic anxiety of the customers in relation to clinical development , within a specified timeline and budget is one of the top priorities for us, who make sure they have a detailed mitigation plan and risk management.
The basic functions include:
Study Feasibility
Site selection and Monitoring
Clinical Trial Supply Management
Monitoring:
There are many ways to create first-rate data with an aim to support the safety and effectiveness claims of a product. The resources are required at potentially huge number of sites. The medical monitoring team at INDTEK takes on these responsibilities, thereby helping you in finding investigator site support and monitoring that is faster and more efficient.
Every BA/BE study and Clinical Development program depends highly on Monitors and the monitors at INDTEK:
Ensure compliance of protocols/SOPs
Apply applicable regulatory requirements, GCP, and SOPs
Support fast recruitment
Help to increase approval of clinical data by the regulatory authorities
Ensure precision and dependability of clinical data
Protect the rights, security and health of your clinical trial subjects
Oversee the advancement of your clinical trial
Safety management:
INDTEK, provides exceedingly reliable inputs for the intend of safety management plans that are complete study specific, with the help of a highly committed and experienced group of Safety Physicians, thereby ensuring there is a regular and accurate reporting and processing of AE’s & SAEs, with compliance to the regulatory guidelines.
The safety management services of INDTEK include:
Perform expedited safety reporting
Medical review of AEs and SAEs
Reconciliation of safety database with CRFs
Coordination, processing and case receipt of AE and SAE
Groundwork for safety narratives
Authentication of AE coding
Reconciliation of SAEs