Services

End to end solutions in Pharma Industry – APIs to Formulations, Non-sterile to all kinds of Sterile dosage forms, Process Development through QbD to cGMP's and all the way to Regulatory compliance and Life Cycle Management.

GMP Audit and Compliance

“FDA like” mock audits to check health of Compliance.
Help industry to incorporate effective Quality Management Systems and practice them in day today work.
Review adequacy of SOPs, Validations, Qualifications to meet International guidance.
Undertake Data Integrity verifications in manual and automated systems of documentation.
Evolve “continuous improvement plan” for Companies in cGMP and monitor for effectiveness checks.
Provide assistance to evolve “Simplification of GMP systems” for improved compliance.
Institute Quality Metrics measurement techniques to reflect product quality/ system robustness within the Organization.

Remediation & Inspection Readiness

Preparation of effective Responses and Corrective Actions to inspectional / audit observations.
Comprehensive support in undertaking remediation w.r.t Warning Letter, Import Alert, Consent Decree of FDA.
Provide tools to track regulatory commitments made to Regulatory Agencies as part of remediation plans.
Institutionalizing Senior management reviews in Quality and Quality systems as per regulatory expectations.
Provide sustainable solutions to complex GMP issues facing pharma companies.

Training & Quality Culture

End to end solutions in Training – Training Need identification, design training modules, effectiveness check of training, qualification and certification of Trainers.
Competency assessment of teams, designing competency enhancement plan, in-house role enhancement / development of people.
Training for mindset change, work ethics, elimination of poor work culture.
Training in Quality Management Systems, SOPs, Validations, Good Documentation Practices and Good Laboratory Practices.

Regulatory Affairs & Lifecycle Management

Preparation of dossiers and submission of Drug Master Files, ANDAs, Market Authorization (MA) applications.
Deficiency responses of dossiers – ANDAs, DMFs, MAs, handling all regulatory queries.
Regulatory pathway for CBEs, PAS, Supplements, Annual updates, Variations.
Regulatory filing in semi-regulated markets.
Regulatory approvals from DCGI, CDSCO, State FDA.