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Our Services

We deliver expert-driven consulting solutions that empower pharmaceutical and biotechnology organizations to achieve regulatory compliance, operational excellence, and sustainable growth. Our services span regulatory strategy, cGMP compliance, validation, manufacturing excellence, and quality systems, providing practical, effective, and tailored solutions to complex industry challenges.
In addition to our consultancy expertise, RAJBIOTEC imports and supplies primary packaging materials for sterile injectable products, including glass vials, glass ampoules, prefilled syringes (PFS), cartridges, and injector pens. We are committed to supporting pharmaceutical manufacturers with reliable packaging solutions that meet stringent quality standards and applicable regulatory requirements.

Regulatory Affairs & Compliance

We provide end-to-end regulatory support to ensure compliance with national and international regulatory requirements throughout the product lifecycle.

GMP Audits & Gap Assessments

Comprehensive GMP audits and compliance gap analyses to identify risks and implement effective corrective actions.

EU Annex 1 & Contamination Control Strategy (CCS)

Expert guidance on implementing EU Annex 1 requirements, contamination control strategies, and sterile manufacturing compliance.

Sterile Manufacturing & Aseptic Process Guidance

Consultancy for aseptic processing, cleanroom operations, media fill programs, environmental monitoring, and contamination prevention.

Quality Assurance & Quality Systems

Development, implementation, and continuous improvement of Quality Management Systems (QMS), SOPs, CAPA, Change Control, Deviations, Risk Management, and Data Integrity.

Computer System Validation (CSV)

Validation services in accordance with GAMP 5 and 21 CFR Part 11, including validation planning, execution, documentation, and compliance support.

Technology Transfer & Process Optimization

Support for successful technology transfer, process scale-up, process optimization, and manufacturing efficiency improvements.

Pharmacovigilance & Drug Safety

Drug safety systems, pharmacovigilance documentation, adverse event management, and regulatory compliance support.

Impurity Assessment & Regulatory Risk Evaluation

Scientific assessment of impurities, risk evaluations, and regulatory strategies to ensure product quality and patient safety.

Animal Testing & Preclinical Support

Consultancy for preclinical studies, animal testing documentation, and regulatory compliance requirements.

Regulatory Inspection Readiness

Preparation for regulatory inspections including mock audits, documentation review, compliance assessments, and employee training.

Training Programs

Customized GMP, GDP, GLP, Data Integrity, Quality Systems, Sterile Manufacturing, and Regulatory Compliance training programs etc.

Import & Supply

We import and supply primary packaging materials (Glass Vials, Glass Ampoules, PFS, Cartridges and Injectors Pens) for sterile injectable products to Pharmaceutical Industries.

Clean Room Consumables

We facilitate and supply clean room consumables including microbiology monitoring media plates.

Supply of Single Use Systems

We support to select single use systems for sterile applications including drug substance, API and fill finish applications.

Professional Skills

We Help You to Grow
Your Business

Our experienced team brings deep pharmaceutical and biotechnology expertise to help organizations overcome challenges, strengthen compliance, improve operational efficiency, and achieve sustainable growth. With a practical, client-focused approach, we deliver tailored solutions in regulatory affairs, GMP compliance, validation, quality systems, and operational excellence—helping your business become stronger, more compliant, and future-ready..

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