Consultancy Services

Audit &
Compliance

We prepare audit plans for companies to qualify for USFDA and European regulatory agencies, and work on remediation programs too to help companies achieve market acceptance.
In conjunction with our mentors we select the right experienced, seasoned and arrange regional consultants for our customers from our pool of data. We believe that you are not alone in this journey and that support is key.

Project
Management

The commissioning of processing plants, laboratories, and environmental health and safety facilities we do is a group effort comprising of experts with more than 30 years’ experience in pharmaceutical companies. We deal with everything from selecting equipment to procuring installation and commissioning continued with doing risk assessment for facility sustainability and safety requirements.

Bio-Pharmaceutical
Resource Training

In partnership with academies, our academy prepares young talent to become valued volunteers in the biopharmaceutical industry with our extended training programs. Saving time and increasing productivity are facilitated by this. The company has industry-trained housewives who are willing to work from home, they will be reviewing and uploading documents to different countries in compliance with their regulations.

Analytical Services &
Method Validations

Ph.D. holders and >15years experienced scientists comprise our method development and validation team. They can provide troubleshooting and develop new methods and transfer them to the other sites. We have a contract with FDA approved analytical laboratories in Bangalore that provide the best services for testing, developing methods, and validating the same.

Licensing &
Regulatory Filings

Our team has mastered the challenges of regulatory filings and studied the cases well. There are a variety of regulatory and licensing experts on our team. In addition to filings in the United States and Europe, we also deal with filings throughout the world.

Other Activities

Procedure
Preparations

As per the latest regulatory and ICH requirements, we prepare procedures for manufacturing and quality control. With our experience, we can provide organizations with the best procedures available. We prepare standard operating procedures and equipment operating procedures, as well as standard testing procedures.

Alternate Vendor
Development Program

As part of our import risk-reduction program, we develop alternate vendors. As a result of large capacity manufacturing outside India, it can be challenging to file KSM for an API since many products are imported. There is a huge demand for KSM in the Indian market. Import de-risking is a government program, and we contribute to replacing imported KSMs with products made in India. We perform end-to-end process, comparative, testing, and initial R & D trials with stability studies.

Export
Activities

According to market studies, herbal extracts and intermediates for API manufacturing are in high demand. Due to the demand, our team exports herbal extracts and intermediates for APIs.

App Based
Services

Our company specializes in providing app-based services for equipment maintenance , supplying essential hospital accessories and laboratory consumables.

Software
Implementations

We are involved in the software implementations like WMS, calculation spreadsheets and software’s to improve compliance in manual operations, digitalisation , authenticated excel sheets calculation sheets etc.

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