Compliance MATTERS

Consulting

The pharmaceutical industry faces a lot of challenges as we are dealing with patients’ safety. To cope with day to day challenges, we need to evolve in every aspect.

We provide an at par consulting service to match the existing regulatory requirements and modernize the operations.

We understand the requirements of our customers and conceptualize those challenges to detailed solutions. As part of our consulting solutions, we have the following different setup and support services.

GMP upgradation

Considered by wide range of suppliers including API & excipient manufacturers and Formulation specialists. Details are as follows.

GMP Consultation

Tailored Audits to client’s unique requirements.
Manufacturing process review to ensure the most efficient process to increase productivity.
Security Assessment and reassurance about minimum risks of deficiencies.
Helping with very fresh approaches, SOPs, software, employee motivation techniques.
Investigation of failure: Issue specific investigation with simultaneous assessment approach
Defining and Setting up procedures for Data Integrity: keeps check on integrity failure
Computer System Validation, IT Setup audits and regulatory compliance

QMS Review

Helped many API plants and manufacturing facilities on system improvement by guiding on systems and infrastructure.
Restructuring the QMS / Quality Assurance System.
Increasing the QMS efficiency
Redesigning the QMS SOPs and Process life cycle management

GCP upgradation (CRO/Site)

Considered by Clinical Research organizations and / or SMO-hospital sites. Details are as follows.

GCP Consultation

Improving the existing systems by guiding on CRO infrastructure and system
Helping with very fresh approaches, SOPs, software, employee motivation techniques.
Identification of Duplication/Over Compliance: To reduce the over documentation and avoiding data duplication
Investigation of failure: Issue specific investigation with simultaneous assessment approach for Clinical, Bioanalytical and PK-Stat processes-data
Defining and Setting up procedures for Data Integrity: keeps check on integrity failure
Computer System Validation, IT Setup audits and regulatory compliance

QMS review

Restructuring the QMS / Quality Assurance System.
Increasing the QMS efficiency
Redesigning the QMS SOPs and Process life cycle manageme

Various areas covered in the consulting service include:

CRO Set-up

Greenfield Development of CRO / Bio-center from identifying

Location
Floor diagrams
Systems and Infrastructure Designing
Procurement
Recruitment and Training
First study execution

Consultancy period till the newly established CRO / Bio-center clears its first regulatory inspection

Improvement through retrofitting modification in existing CROs / Bio-centers

Plant Set-Up and Due Diligence

All kinds of international Audit/inspection success depend on Plant Design.

Set-Up

Pharmaceutical Plant Designing is a skilled job. Wrong design leads us to the failure/rework.
All kinds of international Audit/inspection success depend on Plant Design.
Our GMP expert team handles all kind of Turnkey Pharmaceutical/Biotech Projects and meets the designing demands.
Our knowledge on building constraints as well as regulatory requirements helps us to successfully establish GMP-compliant manufacturing facilities.

Due Diligence

We provide operational due diligence auditing services which is a crucial activity in case of mergers and acquisitions.

Software support

As part of our concept development and consulting solutions, we provide the customers with fresh software concepts to go electronic with process automation. Our experts develop the detailed URS as per wide acceptance in industry and can easily suggest the key data points and processes as per regulatory requirements. With our technology partners, we develop the off the shelf modules and modules as per customers’ requirements.

We offer following specifications in the Software development / process automation:

GxP Training

We partner with our life sciences clients to provide effective, efficient and sustainable training solutions that drive their businesses forward. Our needs-based approach enhances employee and operational performance while mitigating compliance and business risks.From needs assessment through design and delivery, we build sustainable training systems that require minimal resources and are woven through all departments and systems.We drive metrics into the process at every stage to reduce training-related compliance risk, while simultaneously enhancing quality systems to prepare your company for regulatory evaluation.

Licensing

We give assistance to pharmaceutical companies in defining its in-/out-licensing strategy and maximizing the value of their products and technologies. In and out-licensing activities are excellent opportunities for companies that want to quickly expand their portfolio or gain return on investment in a relatively short period. Through our strategic positioning, we can promote and market the products in respective territories. We also assist to companies to register their dossiers in all indicated areas or we may ensure any dossier based on customer´s requirements. Below are the segments.

Licensing

Dossier out license of a product which follow 505(B) (2) regulatory pathway.
Dossier out license of an ANDA.

Product Development

From product search, portfolio development to dossier compilation, contract manufacturing, registration and marketing of the product

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Compliance MATTERS

Consulting

Setup services

GMP upgradation

GCP upgradation (CRO/Site)

CRO Set-up

Plant Set-Up and Due Diligence

Software support

GxP Training

Licensing

Licensing

Product Development

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Compliance MATTERS

Consulting

Setup services

GMP upgradation

GCP upgradation (CRO/Site)

CRO Set-up

Plant Set-Up and Due Diligence

Software support

GxP Training

Licensing

Licensing

Product Development

EXPLORE

CONTACT

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