Pharmaceuticals

Strengthening Compliance and Regulatory Excellence in Pharmaceuticals

Global Pharmaceutical Regulatory, Quality & Compliance Consulting Services

SARACA Solutions is a global consulting and engineering partner and supporting organizations across pharmaceuticals, medical devices, healthcare, and engineering domains. With strong expertise in global compliance, quality systems, and regulatory affairs, we provide Global Pharmaceutical Regulatory, Quality & Compliance Consulting Services and act as a strategic pharmaceutical consultant helping companies accelerate product approvals, maintain compliance, achieve and successful entry into international markets.

Our pharmaceutical expertise includes end-to-end regulatory, scientific, quality, and pharmacovigilance support throughout the complete product lifecycle - from development and dossier preparation to market authorization, post-marketing surveillance, and lifecycle management.

As a global pharma consultant, we support pharmaceutical companies across the United States, Europe, Canada, Australia, ASEAN, and Rest of World (ROW) markets with services including regulatory strategy, CTD/eCTD dossier preparation, CMC documentation, clinical Writing and non-clinical writing, pharmacovigilance, GMP/GDP compliance, quality management systems, labeling compliance, and global regulatory submissions aligned with US FDA, EMA, MHRA, Health Canada, TGA, WHO, SAPHRA, and ICH guidelines. Our Global Pharmaceutical Regulatory, Quality & Compliance Consulting Services are designed to support pharmaceutical companies in achieving regulatory success, maintaining global compliance standards, and accelerating market access worldwide.

Pharmaceuticals/Drug Segments

Analgesics

Analgesics

Antibiotics/Antibacterials

Antibiotics/Antibacterials

Cardiovascular Drugs

Cardiovascular Drugs

Anti-Diabetic Drugs

Anti-Diabetic Drugs

Anti-Cancerous Drugs

Anti-Cancerous Drugs

Gastrointestinal Drugs

Gastrointestinal Drugs

Fixed Dose Combination Drugs

Fixed Dose Combination Drugs

Who We Serve

Pharmaceutical Companies

Generic Drug Companies

OTC Product Companies

Contract Manufacturers

Marketing Authorization Holder (MAH)

Our Service Offerings

Regulatory Affairs and Global Compliance

Regulatory Affairs and Global Compliance

Regulatory Affairs and Global Compliance

  • Global Regulatory Strategy and Support
  • Product Registration Strategy Development
  • Country Specific Regulatory Support
  • Product Lifecycle Management
  • Regulatory Agency Query Response Support
  • Compliance with ICH Guidelines
  • Regulatory compliance as per WHO, USFDA, SAPHRA, MHRA, TGA, Health Canada and EMA
  • CTD, eCTD and ACTD Dossier Preparation & Compilation
  • eCTD Publishing and Validation
  • Dossier Gap Assessment & Remediation
  • FDA 483 Response and Resolution Support
  • Global Regulatory Harmonization
Regulatory Writing and Scientific Documentation

Regulatory Writing and Scientific Documentation

Regulatory Writing and Scientific Documentation

  • Authoring
  • Preparation and Gap Assessment of non-clinical and Clinical documents
  • Module 2.4 Non-Clinical Overview
  • Module 2.5 Clinical Overview
  • Module 2.6 Non-Clinical Summary
  • Module 2.7 Clinical Summary
  • Module 4 Non-Clinical Study Reports
  • Module 5 Clinical Study Reports
  • Scientific Gap Assessment and Documentation Review
  • Product Development Report Preparation
Literature Review and Evidence Evaluation

Literature Review and Evidence Evaluation

Literature Review and Evidence Evaluation

  • Comprehensive Literature Search, Screening and Review
  • Scientific Evidence synthesis for regulatory submission
  • Pharmacology, Pharmacokinetic, and Toxicology Literature review and data Extraction
  • Clinical Safety & Efficacy Literature Review
  • Data Extraction and Evidence Evaluation
CMC and Product Quality Documentation

CMC and Product Quality Documentation

CMC and Product Quality Documentation

  • 2.3 Quality Overall Summary
  • 3.2.S Drug Substance (DMF)
  • 3.2.P Drug Product
  • 3.2.A Appendices
  • 3.2.R Regional Information
  • CMC (Chemistry, Manufacturing, and Controls) Writing and Gap Assessment
  • API (Active Pharmaceutical Ingredient) and Finished Product Documentation Compilation
  • Product Quality Documentation Review
Risk Management and Pharmacovigilance Documentation

Risk Management and Pharmacovigilance Documentation

Risk Management and Pharmacovigilance Documentation

  • Risk Management Plan (RMP)
  • ICH Q9: Quality Risk Management
  • Signal Detection and Management
  • Benefit-Risk Assessment Reports
  • Pharmacovigilance Consulting
  • Periodic Safety Update Report (PSUR)
  • Pharmacovigilance Master File (PSMF)
Quality Assurance and QMS Services

Quality Assurance and QMS Services

Quality Assurance and QMS Services

  • GMP, cGMP & GDP Compliance Support
  • Gap Assessment of Existing GMP, cGMP and GDP
  • Quality Management System Implementation
  • QMS Remediation & Improvement
  • Internal and External Audit Support
  • Investigation and root cause analysis (RCA)
  • Change Control, Deviation, OOS & CAPA Management
  • Procedures Compliance Verification and Validation
  • Computer System Validation (CSV) as per FDA 21 CFR Part 11
Engineering, Validation and Facility Support

Engineering, Validation and Facility Support

Engineering, Validation and Facility Support

  • Equipment Selection and Validation
  • Equipment Qualification (IQ/OQ/PQ)
  • Facility Design & Commissioning
  • Facility Modification & Documentation
  • Facility Qualification & Validation
  • Conceptual Design & Feasibility Studies
  • Pharmaceutical Process Engineering
  • Aseptic Technique SOP Development
SmPC, PIL and Labelling and Artwork Compliance

SmPC, PIL and Labelling and Artwork Compliance

SmPC, PIL and Labelling and Artwork Compliance

  • Reference (Innovator) Product Identification
  • Summary of Product Characteristics (SmPC) Preparation and Gap Assessment
  • Package Leaflet (PL) or Patient Information Leaflet (PIL) Preparation and Gap Assessment
  • Labelling compliance as per eCTD and regional requirements
  • Review of Carton / Label artwork
  • Global Artwork & Labeling Harmonization
Training

Training

Training

  • ISO 9001: 2015 Training
  • GMP / GDP / Pharmacovigilance Training
  • Regulatory Writing training
  • QMS training
  • Labelling and Artwork Compliance Training
  • Audit & Inspection Readiness Training

About Us

SARACA is a rapidly growing product engineering services company with deep expertise in digital, artificial intelligence, and emerging new technologies. Founded in 2014, SARACA is powered by Gen Z and Millennials with greater focus on agility, customer centricity, faster technology adoption, and adherence to cultural sensitivity. Our digital natives perform their actions with speed and ensure that we exceed customer expectation every single time. SARACA adopted vertically integrated approach to build depth in the industries we operate in. Over the years we have built strong expertise in aerospace, defense, space, automotive, medical devices, Industrial, Farm Equipment, rail transportation, technology, semiconductor, and many other industries.

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