What We Offer

Pharmaceuticals

  • We offer practical knowledge and experience on implementing or enhancing Pharmaceutical Quality Systems (PQS) to meet GMP code requirements and those based on ICH Q10 / ISO 9001:2015 for Pharmaceuticals. Modi GMP will work from a series of templates and experiences based on successful past projects and quickly install policies, procedures, work instructions and forms. 
  • Modi GMP Services provides the solutions for practical knowledge and experience on implementing or enhancing Pharmaceutical Quality Systems (PQS) to meet GMP code requirements . We provide services for GMP audits , GMP training , Documentation , compliances to GMP inspections and preparation of CAPA , company Risk Management System , documentation for ISO 9001 / ISO 14000 and OHSAS which includes training , aspects and impacts , HIRA ; CE and ISO 13485 mark related services and documentation, Art-works preparation , gap analysis for pre-inspection etc.

GMP AUDITS

  • We help with GLP, GMP gap audits / assessments and remediation plans to help you prepare for successful GMP audits and inspections from agencies such as the SCHEDULE-M / WHO-GENEVA /TGA/MHRA/US FDA. We carry out GMP audits of the company and provide the solutions also . We also assist in preparing the CAPA .

MEDICAL DEVICES

  • We understand, and implement ISO 13485:2016 (old ISO 13485:2003) Quality Management Systems for medical device manufacturers as well as implementation to meet US FDA 21 CFR Part 820 requirements . We can prepare the Technical Files, assist in audit and audit compliances for Confirmity to EC directives ( CE mark ).

GMP TRAINING

  • We offer a wide range of  GMP training courses, these can be done as individual courses, for company or organization and focused for regulatory agency, i.e. TGA, PIC/S, WHO GMP , US FDA or EU. We can come down to the manufacturing facility and provide on-site training .
  • GMP Training in local language : We provide the training to all groups of participants from workmen ( in Gujarati ) , staff and managerial cadre persons . Training includes the GMP training as well as Personal Development training as per need identified by the company.

DOCUMENTATIONS

  • We can assist the company in establishing the user freindly and compliant documentations for QMS/GMP/GLP/CE mark/RMS etc. Documents will be ensured to be thorouly understood by employees.

COMPLIANCES

  • We can also assist in reviewing the audit observations and offer our services for preparing robust CAPA by guiding the companys technical groups.
  • We offer our services for gap analysis before any audit . This can be followed by the services for documentation, CAPA preparation etc.

RISK ASSESSMENT

  • We can review the company operations and provide services for total Risk Management Services complying latest requirements and expectations for product and process life-cycles. We can identify risks in entire manufacturing operations and assist to mitigate risks wherever identified. Complete documentation for RMS is provided with required training . We can offer services for only documentation or on-site risk assessment by involving the persons doing work.

ISO CERTIFICATIONS

  • ISO 9001 / ISO 14000 AND OHSAS : We offer services for prearing to get ISO certification ; carry out gap analysis , assist to trigger audit from notified body ; impart training for health and safety in parralel with routine GMP operations. We can also take up project for total documentation to comply for these standards and training staff for the routine monitoring.

REGULATORY SUBMISSIONS AND TRIGGER AUDITS

  • We also help to prepare the dossiers, submit and get registered for ROW and SEA countries. We can work to liase with foreign authorities for trigger of GMP inspections.

ART-WORKS AND PREPARATIONS

  • We prepare art-works / preparations for all types of pharmaceutical dosage forms; marketing support by preparing pemphlates upto the satisfaction and as per need of the company. We can also assist in getting them printed and deliver ultimate services. It also includes other art-works for envelopes, visiting cards etc.

THIRD PARTY AUDITS

  • We offer our services for vendor approval of API's manufacturers . We can assist by carrying out GMP audit of such manufacturers and recommend for approval based on audit outcome. We believe in providing solutions also for any of the observations and help for GMP compliances.