Pharmaceutical
We understand the Active Ingredient of Pharmaceutical
The Pharmaceutical industry is faced with an escalation in costs related to the creation of new drugs and rapidly changing regulations. Optimizing costs and minimizing risks require the adoption of new technologies faster. The Pharma industry is required to make a finer balance of spending between ever-demanding innovation and sustaining existing products.
We help our customers to optimize their spending and save costs while improving quality and productivity. These savings will provide additional funds to invest more in innovation and new products.
We have extensive experience in quality assurance and regulatory affairs to ensure that you stay compliant with demanding regulations and produce safer products for your customers. We deeply understand the latest market conditions and global regulatory challenges in the pharma industry.
Quality Assurance, QMS and Data Integration:
- Design quality including GMP and GDP
- Equipment qualification (IQ/OQ/PQ)
- Process validation (OSD/LD/SVP)
- Implementation of new regulations into existing QMS
- Preparation of external audit
- CAPA procedure management and risk management
- Investigation and root cause analysis (RCA)
- Internal and Lead Auditor
- ICH Q9: Quality Risk Management
- Regulatory Compliance per WHO, USFDA, SAHPRA, MHRA, TGA, Health Canada and EMEA
Regulatory Affairs:
- Global regulatory strategy
- Dossier gap analysis & remediation
- CMC writing & regulatory documentation review
- Compliance with ICH guidelines
- Regulatory dossier preparation and compilation for new product registration (CTD, ACTD)
- Computer system validation (CSV) per US FDA 21 CFR Part 11 and Canadian requirements
- Resolution for FDA 483
Quality Remediation and Compliance Verification:
- Revised QMS documents (Change control, Deviation, Investigation, OOS and CAPA procedure)
- Revised compliance verification procedure
- Gap assessment of current procedures with FDA requirements.
- Implementation of procedures and effectiveness verification
- Facility remediation
- Facility modification and documentation (HVAC qualification)
- Facility qualification and temperature mapping
- Aseptic technique SOP
CLIENT TESTIMONIALS
We work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.
“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”
