Simpruv offers integrated services to deliver measurable results for clients as they prevent and resolve compliance problems and develop new products for regulatory submission and approval by regulatory agencies. Simpruv has a very effective, systematic and rationale approach in providing services efficiently.
Preventing and resolving compliance issues is at the heart of Simpruv team members experience and expertise. Through our integrated services, which includes the support of our scientific and technical experts, Simpruv can provide specific, actionable recommendations to clients. The Simpruv integrated services for FDA includes:
- 1. GAP Assessment
- 2. Document Preparation and Review
- 3. Compliance Problem Resolution
- 4. Training
- 5. Pre-inspection Audit
- 6. Audit Support
- 7. CAPA Support
With increase in the outsourcing of Finished Products, APIs, KSMs from Asia there is a sudden surge in compliance demand. Simpruv with its team of CEFIC/APIC/ASQ/CQA Certified auditors can provide end-to-end service and facilitate in getting client’s facility approved by competent EU/ WHO/ PIC/s Authorities and realizing their objective for establishing their potential presence in International Markets.
Simpruv offers a wide range of Pharmaceutical Regulatory Services. Simpruv provides the unique combination of in-house expertise in Regulatory Affairs that is strengthened by an established Consulting network; experts in many markets who bring specialist and in-depth understanding, and where needed, local market intelligence to your project. The following services are integral to the regulatory services of Simpruv.
- 1. DMF Preparations/Submissions
- 2. Dossier Preparations/Submissions
- 3. Pharmacovigilance
- 4. MA Holding
- 5. EU Importation & Batch Control / Batch Release
Simpruv offers extensive training programs for all its clients covering all areas of Compliance. While trainings are conducted, wherever needed after the audits, Simpruv also arranges training sessions for QA and Manufacturing personnel of clients, keeping them abreast with latest regulatory requirements and market challenges. Simpruv has certified trainers to conduct the training for all levels of professionals ranging from bench chemists to Senior Management, and with the right approach based on the user requirements.