Pharmaceutical Technology Solutions
Comprehensive technology solutions for pharmaceutical companies. R&D management, regulatory compliance, production tracking, and pharmaceutical software that ensures safety and efficacy.
Complete Pharmaceutical Solutions
Advanced pharmaceutical technology solutions that accelerate drug development, ensure compliance, and optimize manufacturing processes for pharmaceutical companies.
R&D Management
Comprehensive research and development management with clinical trial tracking, protocol management, patient enrollment, and data collection systems to streamline drug development processes.
Regulatory Compliance
Built-in FDA, EMA, and global regulatory compliance management systems with automated documentation, audit trails, and compliance reporting to meet all pharmaceutical regulations.
Manufacturing Execution
Advanced manufacturing execution systems (MES) for pharmaceutical production with batch tracking, quality control, and production monitoring to ensure product quality and compliance.
Document Management
Comprehensive document management system for SOPs, batch records, quality documents, and regulatory submissions with version control and electronic signatures for 21 CFR Part 11 compliance.
Supply Chain Management
Advanced supply chain management with raw material tracking, supplier qualification, cold chain monitoring, and distribution management to ensure product integrity throughout the supply chain.
Quality Assurance
Comprehensive quality assurance systems with CAPA management, deviation tracking, quality testing, and validation management to ensure pharmaceutical products meet the highest quality standards.
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Transform Your Pharmaceutical Operations
Accelerate drug development and manufacturing with cutting-edge technology solutions that ensure compliance and enhance efficiency.
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Direct answer
What Synoviq delivers for pharmaceutical
Synoviq builds GxP / 21 CFR Part 11 validated systems for pharma across AU, IN, UAE, UK, USA, IE, and SG. We deliver CTMS/eTMF/RIM integrations (Veeva, Medidata, Argus), pharmacovigilance case intake with E2B(R3) submissions, eCTD replatforming, serialisation (DSCSA/FMD/DAVA), and cold-chain IoT. Validation deliverables (URS→PQ) are produced as part of scope, not billed later.
Questions answered
Frequently asked questions about Pharmaceutical
Direct, evidence-backed answers for teams evaluating Pharmaceutical partners. Emitted as FAQPage schema for rich-result eligibility and AI answer engines (ChatGPT, Perplexity, Gemini, Claude).
- Do you build GxP / 21 CFR Part 11 compliant systems?
- Yes. We deliver validated systems across CSV (Computer System Validation) practices: URS, FS, DS, IQ, OQ, PQ, trace matrices, and periodic review. Electronic records carry audit trails, e-signatures, version control, and tamper detection aligned with 21 CFR Part 11, EU Annex 11, and WHO TRS 986 Annex 4.
- Which CTMS, eTMF, and RIM platforms have you worked with?
- Veeva Vault (Clinical, Regulatory, Quality, Safety), Medidata Rave, Oracle Siebel CTMS, Oracle Argus Safety, ArisGlobal LifeSphere, Montrium, and Florence eTMF. Bespoke extensions include custom dashboards, workflow bridges, and retirement-from-legacy migrations with SOP-documented data integrity.
- Do you support pharmacovigilance and adverse-event workflows?
- Yes. We build case-intake portals, MedDRA-aligned triage, E2B(R3) gateway submissions, signal detection pipelines (ICSR volume anomalies, PRR, ROR), and MHRA/FDA/EMA/CDSCO regulatory submissions. AI-assisted duplicate detection and natural-language narrative generation reduce case-processing time by 30–50%.
- Can you help us modernise a legacy regulatory submission stack?
- Yes. We replatform eCTD submissions from on-premise (Lorenz docuBridge, Extedo eCTDmanager) into Veeva Vault Submissions or AWS-hosted equivalents with backwards-compatible document lifecycle. Historical submissions are re-indexed, DQ-validated, and mapped to ICH M4 / M8 structures without disrupting live filings.
- Do you handle cold-chain and serialisation (DSCSA, FMD) requirements?
- Yes. Serialisation (GS1 SSCC/SGTIN), aggregation, and cold-chain IoT (temperature loggers, lane exceptions) feed a central supply-chain data platform. Verifications against DSCSA (US), FMD (EU), Track & Trace (UAE, KSA), and India DAVA are produced with exception handling and wholesaler EPCIS exchange out of the box.