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Pharmaceutical Manufacturing Compliance Support Services

For APIs, finished dosage forms, biologics, and medical devices (including IVD), we provide end-to-end compliance support under GMP/QMS requirements, covering document system development, validation and qualification, consistency checks of manufacturing documentation, and inspection readiness.
Pharmaceutical companies, medical device manufacturers, CDMOs/CMOs, enterprises planning new facilities or expansions, and heads of regulatory affairs, QA, and production

Apply for Initial Manufacturing Compliance Assessment Download Service List (PDF)

  • Pain Point：Common Pain Points

    Documents are complete but "unclear," making it difficult to explain during reviews/inspections;

    Inconsistencies among process validation, batch records, and registration dossiers lead to supplementary requests or delays;

    Incomplete materials related to CSV/DI (Computerized System Validation/Data Integrity);

    Inability to quickly align manufacturing changes with registration and marketed materials;

    Regulatory differences across multiple markets require repetitive adaptation of manufacturing documents.

    VS

    Solution：Our Approach

    Establishing a traceable document link from the "manufacturing site" to "regulatory submission";

    Embedding the review/registration perspective during the document preparation phase to significantly reduce the risk of late-stage supplementary requests;

    Systematically aligning validation, batch records, and process parameters with registration dossiers to form an auditable evidence chain.

Standard Workflow

  • 01
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    Initiation and Goal Confirmation

    Clarifying product types, target markets, timelines, and compliance boundaries.

  • 02
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    Current State Assessment（Gap Analysis）

    Comparing documents, processes, validation, and registration dossiers.

  • 03
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    Strategy and Roadmap

    Developing plans for document revision, supplementary validation, submission preparation, and inspection readiness.

  • 04
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    Document and Evidence Construction

    SOPs, BMRs, validation reports, CSV documents, and alignment with registration materials.

  • 05
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    Internal Verification and Mock Inspections

    Multiple rounds of internal audits, mock inspections, and on-site rehearsals.

  • 06
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    Delivery and Maintenance

    Submission dossier packages, remediation support, long-term versioning, and variation management.

Quality Control Points

  • 01
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    Regulatory citations and cross-referencing

    applicable guidelines, regulatory clauses

  • 02
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    Logical consistency across documents

    process ↔ batch records ↔ validation ↔ registration

  • 03
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    Consistency of terminology and parameters

    utilizing centralized termbases

  • 04
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    Traceability and version control

    change records, approval chains

  • We do not just "write documents"; we craft them into a "chain of facts that reviewers can understand."
  • Directly aligning process and validation activities with eCTD/CMC materials to reduce information asymmetry.
  • Joint support from QA, CMC, process, validation, CSV, and regulatory experts.
  • Unifying parameters, terminology, and templates to reduce repetitive review costs.
  • Supporting integration with our proprietary eCTD platform and clients' DMS (Document Management System) to ensure lifecycle management.

Initial GMP Submission Support for New Facilities
Problem

Several inconsistencies existed between documents and on-site operations, and the logic of validation reports was fragmented.

Solution

Executed Gap Analysis → Unified SOP and BMR templates → Restructured validation reports and supplemented necessary data explanations → Conducted mock audit rehearsals.

Results

Inspection readiness improved, the number of required remediation items significantly decreased, and the client saved on review communication costs.

Registration Supplements Triggered by Manufacturing Changes
Problem

Critical process parameters were not synchronously updated in the registration dossiers after process scale-up.

Solution

Collaborated with the CMC team to restructure the Module 3 content → Generated supplement explanations and data summaries → Adjusted batch record templates and synchronized CSV change logs.

Results

Supplement preparation time was shortened, and responses to regulatory Q&A became more evidence-based.

Quality System Remediation Support Prior to Overseas GMP Audits
Problem

Before an overseas GMP audit, a pharmaceutical company discovered non-compliant practices in deviation management, CAPA records, and data integrity documents.

Solution

Conducted a comprehensive Gap Assessment of the quality system → Streamlined deviation and CAPA workflows → Optimized data integrity management standards → Provided mock audits and Q&A coaching.

Results

The standardization of quality system documents significantly improved, on-site audit communication became smoother, and the overseas client audit was successfully completed.

Global Consultation Hotline：400 680 7218
21st Floor, Building 19, Zhonghai Xin Innovation Industry City, Jihua Street, Longgang District, Shenzhen
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