At ROPRA, we are dedicated to delivering end-to-end consulting services in pharmaceutical, medical device, and life sciences industries. Our expertise spans multiple areas, ensuring comprehensive support for your regulatory and development needs.
- Preparation and submission of regulatory dossiers (e.g., eCTD, US DMF, ASMF, CEP) for new products.
- Lifecycle management, including all major and minor variations, updates to pharmacopoeial standards, and handling CEP variations.
- Regulatory strategies, gap analysis, and change-control assessments.
- Support with responding to deficiency letters and requests for information from regulatory authorities.
- Preformulation and reformulation studies for excipient compatibility, stability testing, and physicochemical analysis.
- Development of diverse dosage forms, including tablets, capsules, oral solutions, sterile products and effervescent products.
- API process optimization, impurity profiling, and stability studies in line with ICH guidelines.
- Comprehensive BA/BE studies for generics and innovative formulations.
- Clinical trial applications, protocol design, and monitoring.
- Analytical method development, validation, and gap analysis to ensure compliance with international pharmacopeias.
- Preparation of patient information leaflets (PILs), Summary of Product Characteristics (SmPCs), and label mock-ups.
- User testing of PILs and strategic support for post-approval changes.
- We provide specialized consulting for medical device manufacturers and distributors, representing regulatory requirements in India, the USA, the EU, the UK, and other global markets:
- Classification and regulatory strategy for medical devices and in vitro diagnostic (IVD) devices.
- Preparation and submission of technical documentation, including Design Dossiers and Device Master Files (DMF).
- CE marking support under EU MDR/IVDR and UKCA marking under UK MDR.
- US FDA 510(k), De Novo, and PMA submissions.
- CDSCO (India) guidance for import/manufacture licenses, clinical investigations, and registration processes.
- Post-market surveillance (PMS), vigilance reporting, and complaint handling.
- Labeling and UDI compliance for global markets.
- Assistance with quality management systems (QMS) implementation aligned with ISO 13485.
- Audits and readiness support for inspections by notified bodies, FDA, and CDSCO.
- GMP compliance guidance for pharmaceutical manufacturing.
- QMS implementation for medical devices (ISO 13485, 21 CFR Part 820).
- Strategy to identify and qualify suppliers of APIs, raw materials, and device components.
- Sourcing APIs, intermediates, generic drug formulations, and medical device components through our global network.
- Translation services for regulatory and technical documents across multiple languages.
- Package design for pharmaceutical and medical device products.
Email: contact@ropra.org
UK: +44 203 9597 934
India: +91 832 80 16 464
Website:www.ropra.org
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