We work with our client's standard offers comprehensive Pharmaceutical Regulatory Affair Service with extensive experience and effective project management. Our committed to Quality and service excellence will bringing out client's trust both professionally and personally.
To be the client's first choice for services, respected for preserving our culture and values of customer satisfaction, Innovation and responsibility.
To provide affordable & accessible services which are process centric, Technology enabled and people oriented resulting in reliable, scalable and sustainable change.
Services you can trust...
Standard Operating procedure
Documentation is the heart of Pharma Industry. We prepare Step-by-Step instruction, compiled in the form of Standard Operating procedure to achieve efficiency, Uniformity of performance and Quality.
Facility Design Consultation
Building design plays a critical role in any industry. Our Technical Team help in ensure the best outcomes and maintain alignment through out the process for Facility design practice.
Cleaning Validation
Cleaning validation demonstrate a high degree of Assurance of Cleaning process. We perform the overall cleaning validation documentation activity .
Third Party Audit
We are performing third party GMP audits of Pharmaceutical medicine, Active pharmaceutical Ingredients, Raw Material and Intermediate.
Document Preparation & Compliance
Documentation and compliance consist of records & reports of information required to verify the implementation of compliance program in place. We prepared complete documentation e.g. SOP, Protocol & Reports, BMR/BPR, Validation Studies.
Equipment/ Instrument Commissioning & Qualification
We perform a series of inspections, test and assessments to ensure that your equipment or Instrument in reliable performance stage.
Risk Assesment
Risk assessment in pharma entails the identification of hazards as well as investigation and assessment of the risks connected to exposure. We asses the all the risks associated during manufacturing of your products with their mitigation plan.
Trainings
Our Professional Team provide the GMP, GDP, GLP, GEP and other Quality Training.
GAP Analysis
All the existing GAP associated with manufacturing of product in Plant, Documentation and any other regulatory requirement are assessed by our technical team between current practices and regulatory affairs services guidelines.
Meet Our Specialist
Behind the word mountains, far from the countries Vokalia and Consonantia, there live the blind texts. Separated they live in Bookmarks grove right
Get in touch with us