Our services

What We Do

Acesst Pharmatech provides services in Quality Assurance and cGMP for Pharma and Medical Devices

All the Regulated industries/companies are compliant same as their vendors/suppliers any noncompliance with regulations at the vendor/supplier are liabilities of the company. Company is held responsible for its vendor/supplier qualification and its oversight.

With increasing globalization of operations, vendors/supplier for all aspects of development are involved at all geographic locations. Most discussions for foreign vendor/supplier qualification are limited to manufacturing operations while clinical trials, centralized labs, and animal testing facilities have an almost equal probability of being located at a foreign site. It works both ways, company using bad vendors suffer the financial, regulatory and legal consequences, while for vendors with bad history, it is hard to find new business. Hence, just like the regulated company, vendors also need to assure that the client is suitable and will not cause major issues later.

Secondly, If your company is marketing a product or service that is regulated by the FDA, you should be prepared for an FDA audit. If you have never been audited by the FDA you need to prepare for the same or if you were last audited 4-6 years ago, if any product you supplied has been in the news – positive or negative, or if you are getting ready to submit a marketing approval application, chances are you would get audited by the FDA in the near future. Although different facilities are subject to different regulations, FDA auditors follow some general guidelines that are common across all.


Plant layout designing for Sterile and Non Sterile facilities like Tablets, Capsules, Injectable and R&D Labs as per International c GMP norms and Project Execution. To design HVAC, Water Systems etc.


Auditing for different regulations i.e. 21 CFR Part 210,211,21 CFR Part 111,21 CFR Part 820,ICH Q7A,21 CFR Part 820,EU GMP,ISO 9001,ISO 13485,Mock Audits, Gap Assessments, Supplier Audits & Third Party Audits

GMP Compliance Advice

:Advice on the preparation for and the undertaking of Quality System Management Review meetings necessary to comply with ISO 13485 and FDA QSR requirements

Quality Assurance

Qualifications and Validations, Quality Assurance Systems, Quality Control Systems , Production Systems, Warehouse Systems, Trainings for the new facility as per FDA, MHRA, PICs norms.

Examination & Diagnosis

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Quality Systems designing

Revamping of QMS for Tablets, Capsules, Injectable, Biotech and API facilities to meet national and international regulatory requirements and expectations.

Qualifications and Validations

Analytical Method Validation, Process Validation, Cleaning Validation, CSV, Qualification and Validation of Utilities like Water System, HVAC, Instruments, Equipment, and Facility etc

GAP Analysis

Facility against Schedule M, GAP Analysis of Laboratory against Schedule L1 and other requirements as per EU, MHRA, US FDA and other international regulatory requirements.


Preparation of documents like VMP, SMF, SOPs, URS, DQ, IQ, OQ, PQ, VMP, SOPs, SMF etc as per regulatory requirements.

Quality Control

Designing and qualification of Analytical Laboratories as per international regulatory requirement.


GMP, GLP and QMS Trainings to develop knowledgeable workforce

Audit preparation

Assistance in audit preparation and compliance to the Audit observations.


DCGI and FDA Communications, Dossier preparation etc

Equipment selection

Its for new and old projects.

Risk Assessments and mitigations Techniques.

Assistance in audit preparation and compliance to the Audit observations.


Process Standardization, Yield Improvement, Troubleshooting.

Effective Media

Fill and improvement of aseptic practices

Formulation Development

Assistance in audit preparation and compliance to the Audit observations.

Trouble shooting

Assistance in audit preparation and compliance to the Audit observations.