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 improve submission readiness, regulatory compliance, and global market access strategies.
Our Global Pharmaceutical Regulatory, Quality & Compliance Services 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.
Through our Global Pharmaceutical Regulatory, Quality & Compliance Consulting Services 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
Antibiotics/Antibacterials
Cardiovascular Drugs
Anti-Diabetic Drugs
Anti-Cancerous Drugs
Gastrointestinal Drugs
Fixed Dose Combination Drugs
Who We Serve
We partner with a diverse range of organizations across the life sciences industry, providing solutions to meet their regulatory requirements. Our expertise supports pharmaceutical innovators, generic manufacturers, over the counter (OTC) product companies, contract manufacturing organizations, and marketing authorization holders (MAHs).
Pharmaceutical Companies
Organizations focused on discovering, developing, and commercializing innovative medicines to address unmet medical needs.
Generic Drug Companies
Organizations that manufacture cost-effective alternatives to branded medicines while ensuring equivalent quality, safety, and efficacy.
OTC Product Companies
Companies that develop and market non-prescription medicines designed for safe and effective use by consumers without medical supervision.
Contract Manufacturers
Organizations that offer outsourced manufacturing services, ensuring quality, compliance, and efficient production of pharmaceutical and healthcare products.
Marketing Authorization Holder (MAH)
Organization that owns the license to sell a drug and ensures it meets all regulatory, safety, and quality requirements throughout its lifecycle.
Our Service Offerings
Regulatory Affairs and Global Compliance
Regulatory Affairs and Global Compliance
Regulatory Writing and Scientific Documentation
Regulatory Writing and Scientific Documentation
Literature Review and Evidence Evaluation
Literature Review and Evidence Evaluation
CMC and Product Quality Documentation
CMC and Product Quality Documentation
Risk Management and Pharmacovigilance Documentation
Risk Management and Pharmacovigilance Documentation
Quality Assurance and QMS Services
Quality Assurance and QMS Services
Engineering, Validation and Facility Support
Engineering, Validation and Facility Support
SmPC, PIL and Labelling and Artwork Compliance
SmPC, PIL and Labelling and Artwork Compliance
Training
Training
Our Expert Team
At Saraca, we have a team of 50+ medical writers, regulatory affairs professionals, and scientific professionals who have successfully supported the development, registration, and lifecycle management of products. Our expert team has wide experience in pharmaceuticals and comprehensive experience in managing and supporting over 250+ products across a wide spectrum of therapeutic areas. Our team possesses extensive experience in developing high-quality regulatory, scientific, clinical, non-clinical, quality, and pharmacovigilance documentation in accordance with national, international, and regional regulatory requirements. We support pharmaceutical manufacturers, marketing authorization holders (MAHs), contract research organizations (CROs), and healthcare companies in preparing submission-ready documents that meet the requirements of health authorities worldwide.
Our expert team has experience with a diverse range of products, including oncology (anti-cancer), anti-diabetic, gastroenterology products, antibiotics, and other specialty and prescription pharmaceuticals. We support manufacturers and Marketing Authorization Holders across the product lifecycle with regulatory strategy, scientific writing, compliance solutions, and commercialization support to bring products to market efficiently and successfully.
Project Range
Engineers with Domain Experience
Specialists in Global Regulations
Medical Writers
How We Work
Assessment & Gap Analysis
- Identify Gaps in the existing files
- Highlights risks, inefficiencies or missing information
Planning & Strategic Development
- Define clear objectives and timelines
- Determine resource, responsibilities and methodologies
Document Preparation & Execution
- Creation of required documents
- Update the existing files
Review & Compliance Verification
- Check alignment with regulatory, internal or client standards
- Identifies errors or gaps
- Necessary revisions and validations
Deliverable & Submission
- Finalization of documents
- Submission of document to Client
- Feedback Collection
Assessment & Gap Analysis
- Identify Gaps in the existing files
- Highlights risks, inefficiencies or missing information
Planning & Strategic Development
- Define clear objectives and timelines
- Determine resource, responsibilities and methodologies
Document Preparation & Execution
- Creation of required documents
- Update the existing files
Review & Compliance Verification
- Check alignment with regulatory, internal or client standards
- Identifies errors or gaps
- Necessary revisions and validations
Deliverable & Submission
- Finalization of documents
- Submission of document to Client
- Feedback Collection
