Get More Done with

BS Associates

Customer and Regulatory audit support with Compliance

DMF preparation
eCTD conversion
HR Mangement
System

Training
Mangement

Get More Done with

BS associate

Customer and Regulatory audit support with Compliance

DMF preparation
eCTD conversion
HR Mangement
System

Training
Mangement

ABOUT US

The company leads entire
SOPs process from our
concept.
SOPs & Other GMP Document Preparation
Standard Operating Procedures (SOPs) must be written, approved and followed for any operation, activity or task that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient, medicinal product or medical devices to ensure consistent application.

1560+

Project Delivered

100+

Professional

950+

Happy Client

10+ Yrs

Experience

Read about Us

OUR
EXPERTISE

Process, Cleaning and Analytical
method validation (on site or off site)
Analytical methods used for measuring residues in cleaning validation protocols should themselves be validated. This validation usually means following standard industry practices for the validation of analytical methods.
Software Services (Customized with compliance as per 21CFR Part-11)
With 21 CFR Part 11, the FDA ushered in the use of modernized technology for records and submissions. The regulation made electronic records and signatures as valid as paper records and handwritten signatures.
Training on GXP and Guidelines
GxP training is a vital practice in the biopharmaceutical industry, and the best way to make sure that your program is current and aligned with your organizational.
Customer and Regulatory audit support with Compliance
A compliance audit is a comprehensive review of an organization’s adherence to regulatory guidelines. Audit reports evaluate the strength and thoroughness of compliance preparations.
GAP analysis and Site Audit
Good Agricultural Practices (GAP) audits are voluntary audits that verify that fruits and vegetables are produced, packed, handled, and stored to minimize risks of microbial food safety hazards.

OUR SERVICES

DMF preparation, review, eCTD conversion and submission to
Regulatory Authority (USFDA, EDQM, ANVISA,CHINA and other countries)
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Technical Support
Technical support refers to services that entities provide to users of specific technological products or services.
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Testing Management
Test Management is a process where testing activities are managed to ensure high-quality.
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Development
Development is a process that creates growth, progress, positive change in economic, environmental.
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OUR PROCESS

The process we are working
with our client worldwide
To deliver on the promise of technology and human ingenuity.
We help our clients become the next and best versions of themselves.

01

Electronic Document
Management

Electronic document and records management system is a type of content management system and refers to the combined technologies of document management.

02

Material Management

Materials management is a core supply chain function and includes supply chain planning and supply chain execution capabilities.

03

APQR preparation

Annual product report shall prepare for all finished products manufactured. Raw materials. Packing materials. Finished product to identify any emerging trends as also to identify product / process related improvements.

04

Laboratory Management
system

A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory’s operations.

05

HR Mangement System

An HRMS, or human resources management system, is a suite of software applications used to manage human resources and related processes throughout the employee lifecycle.

06

Training Mangement

The application of knowledge, skills, tools and techniques to training activities to realize the outcome of training. Training Management Cycle: A conceptual framework to manage the training as a cycle including the steps of planning, implementation, and evaluation.
Our customers love
what we do
Transform your idea into reality
It is a long established fact that a reader will be distracted by
the readable content of a page when looking at its layout.
Elemental impurity analysis method development, validation
Qualification is the process of acquiring and evaluating data that establishes the biological safety of an individual impurity or a given impurity profile at the level(s) specified.
Genotoxic Risk Assessment Report preparation by QSAR or equivalent software
The genotoxic substances induce damage to the genetic material in the cells through interactions with the DNA sequence and structure.

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Let’s make
something special
Get More Done with BS associate Customer and Regulatory
audit support with Compliance.The company leads entire
SOPs process from our concept.

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