Feel free to reach out to us at 095588 09128 or visit our office at 102, Shraddha Saburi, Narayan Gardens, Vuda Road, Gotri, Vadodara, Gujarat 390021.

Service’s

Audit, GAP analysis & Compliance

  • GAP analysis / Due Diligence for Pharmaceutical companies to check the health of GMP compliance
  • Mock audits/Gap analysis in line with FDA /MHRA/ PMDA/TGA/EDQM/WHO to ensure the compliance status
  • Gap analysis according to PIC/s compliance requirements
  • Internal review / audit/Self inspection support
  • Periodic review for systems, follow-up audits
  • Support industries to develop effective and compliant Quality Systems to practice them on routine basis.
  • Third party audit (On behalf of overseas end users / customers for Finished product, API, Raw Materials, Excipients, intermediates and Packaging Materials
  • Develop continuous improvement plans to check effectiveness and updating of GMP standards.
  • Review adequacy of Documentation, SOPs, Validations, Qualifications to meet International regulatory standards.
  • Data Integrity verifications support in electrotonic, paper based and chromatographic and spectral documentation to compliance status.

Training & Quality Culture Build up

  • Customised GxP Training Programs
  • Training Need identification, design of customised training modules
  •  Training effectiveness check, qualification and training the trainers & Internal Trainers certification programme.
  • GxP/ QMS auditor development and qualification training
  • Regulatory Affairs Training
  • Quality System Training Programs
  • Training for GxP, Quality Systems, SOPs, Validations, Qualifications, Good Documentation Practices and Good Laboratory Practices
  • On job training programs
  • Professional development workshops and conferences
  • GxP Internal Auditor Development Certification Programme
  • SOP Trainings
  • Attitudinal and behavioural Trainings to change mindset, work ethics and build-up of quality culture.
  • Demonstration Trainings for enhancement of Employee knowledge, skills, ability and competencies.

Vendor /Supplier qualification

  • We undertake risk-based audits for ensuring compliance with regulatory, quality and GMP standards
  • Helping vendor development and evaluation for Finished product, API, Raw Materials, Excipients, intermediates and Packaging Materials
  • Auditing Vendor Quality System compliance (Vendor qualification support)
  • Auditing Contract testing Laboratory for Method development & Analytical Method Validation
  • Auditing Contract Manufacturing Facilities and Service Providers for GMP compliance
  • Periodic review for quality systems, follow-up audits
  • Assist in risk assessment of vendors/suppliers and contractual service providers
  • Extending support for meeting regulatory requirements

Validation and Qualification

  • Preparation of Validation Master Plan
  • Facility Qualification
  • Equipment Qualification
  • HVAC/AHU System Qualification
  • Utilities like Water System/ Compressed Air/Steam System etc
  • Laboratory Instrument Qualification
  • Vendor Qualification
  • QC Analyst Qualification
  • Temperature and Humidity Mapping of Storage Areas
  • Analytical Method Validations
  • Process Validations
  • Cleaning Validations
  • Water System Validation
  • Computer System Validation
  • Requalification & Revalidation

Documentation and SOP management Support

  • Design of documentation templates/formats for ADL, QA, QC, Microbiology, Warehouse, RA functions, Manufacturing, IT and Engineering functions
  • Assist in development of Specifications, Analytical Procedures, Standard operating procedures, Protocols, Policies, formats, templates, Instruction, Checklists  Record and Report templates.
  • Analytical method development and validations
  • Internal review / audit / Data integrity
  • Sampling, Statistical Trend, Stability and other laboratory system implementation & review.

Preparing for Global GMP and Regulatory Compliance

  • Review of existing GMP systems to check the status of compliance and to identify gaps
  • Gap analysis to review of current practices being followed to check compliance with the GMP regulations and quality standards.
  • Support to implement corrective actions to ensure adherence to regulatory requirements.
  • Gap analysis of new facilities for the of development GMP and Quality Systems
  • Gap Analysis of existing facilities to identify the disparities and support them to comply with regulations, GMP and Quality Standards.

Regulatory Affairs and Compliance Services

  • Regulatory filings of generics ANDA/ANDS/MAA etc. to US, Europe, Canada, Japan, ASEAN Countries, TGA, ANVISA and ROW (Rest of the world) markets
  • Technical Data Package Development at R&D stage of product
  • Drug Master Files preparation, review, compilation, validation and submission for APIs, Excipients and Packaging Materials
  • CEP/COS preparation, review, compilation, validation and submission for European Pharmacopoeial Products (EDQM)
  • USP Verification (Drug Substances and Excipients)
  • Dossier preparation, review, compilation, validation and submission as per Common technical dossier (CTD/eCTD) format/   Common Technical Dossier (ACTD) Guidelines / South Africa (MCC-MRF-1) Guidelines/ Brazil ANVISA/ WHO API/FPP Pre-qualification, CDSCO, India Guidelines.
  • Critical Review of Dossier and Preparation of GAP Analysis Report
  • CMC-Writing, SOP Writing, Protocol Writing, Expert report (QOS) preparation
  • Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR, Mfg. Formula, Mfg. Process etc.
  • Consulting and preparation of all five  CTD modules (M-1, M-2, M-3, M-4, M-5) for registration purpose in any country .
  • Re-formatting old Dossier/DMF, NTA to CTD/eCTD format.
  • Regulatory Compliance Audits
  • Guidance and Counselling of Pharma students
  • Training and Development of Pharmacists, RA/QA/QC/ADL Associates
  • Grooming and Mentoring future leaders in Pharma ADL/QC/RA/QA/
  • R & D/Clinical field
  • Response preparation to the customer and regulatory authorities’ queries

We support our esteemed customers for life cycle management of registered drug substances and drug products for regulatory pathway:

  • Amendments
  • Annual updates,
  • Query/Deficiency responses
  • Request to information etc.
  • Post approval changes
  • CBE0
  • CBE30
  • Prior Approval Supplement (PAS)
  • Variation Filing
  • Re-registration

GMP & Regulatory Remediation

  • Review adequacy of SOPs, qualification and validation to meet compliance according to international quality standards.
  • Provide systematic and effective response and corrective and preventive action (CAPA) to the audit/ inspection observations.
  • Extend support for extending the remediation for FDA 483 observations, warning letters, import alerts, consent decree and preparation support for FDA pre-meeting questions response, presentation materials and meeting agenda.
  • Providing sustainable solutions for GxP, Quality and Regulatory Issues
  • Provide solutions for making quality systems robust, effective and flawless
  • Support in preparation and implementation of continuous improvement action plans and putting them into practice.

Strategic Outsourcing Support

  • We provide strategic outsourcing support to pharmaceutical manufactures with strong focus on GMP, Quality and Regulatory Standards
  • Intellectual property rights protection
  • Outsourcing from regulatory and GMP compliant facilities
  • Assurance for quality, quantity and timely delivery.
  • We develop outsourcing partners for you by auditing their GMP and Quality Standards.

GMP compliant building and facilities design & Compliance

  • GLP Compliant Chemical & Microbiology Testing Quality Control and Analytical Development Laboratories Layout design
  • GLP Compliant Chemical & Microbiology Testing Quality Control and Analytical Development Laboratories Setup
  • GMP compliant Raw material, packaging material warehouses and finished product storage area layout design input and commissioning support
  • GMP compliant API and FPP Manufacturing facility layout design input and commissioning support
  • GMP compliant R&D and F&D facility layout design input and commissioning support
  • Regulatory Input in the upcoming manufacturing facilities
  • Technical Discussions for the existing and upcoming facilities

Risk Assessment

  • Risk Identification of procurement, supply chain, storage, testing, manufacturing process, product, distribution, quality systems, facilities, equipments and utilities
  • Risk categorisation and impact assessment
  • Conducting Detailed Analysis of identified Risks
  • Evaluation of identified risks
  • Development of risk mitigation strategies
  • Establishment of a system for ongoing monitoring and review of identified risks
  • Risk Assessment Process Documentation Support
  • Foster effective communication about identified risks and their mitigation strategies
  • Encourage a culture of continuous improvement by using ongoing monitoring and review to enhance the risk assessment process.

Technology Transfer

  • Design of comprehensive plan outlining the technology transfer process, protocols, timelines and establishment of responsibilities
  • Ensuring regulatory compliance requirements
  • Intellectual property management agreements
  • Rigorous quality assurance measures to maintain integrity and consistency of transferred technology.
  •  Risk Assessment and mitigation strategies
  • Training and skill transfer
  • Communication and collaboration
  • Manufacturing Process Optimization support
  • Post Technology Transfer Support

Continuous Improvement

  • Adherence to Regulations and timely updating
  • Continuous improvement efforts within the Quality System
  • Risk-based approach for ensuring product safety and compliance.
  • Structured Approach for Efficient Problem Resolution
  • Data-Driven Decision Making
  • Supplier Quality Management
  • Continuous improvement in the Quality System
  • Training and Skill Development
  • Customer Satisfaction