Consultants of
Happy Scientifics Limited ®
Wide experiences in modern Life Sciences industry - Medical Devices, Pharma, Diagnostics and Biologics
Dr. Jafor Ullah, MD
New York US
Expert in Medical/IVD Devices in Quality/ Regulatory Compliance, Lead Auditor, DHF (Design History File) Remediation, MDR/IVDR Transition, Computer System Validation, System Verification and Validation as well as the trainer with 13 years of experience in Medical and Health care domain.
Anitha Kalaisenvan
Chennai, India
Anitha is a dedicated and focused Clinical Research
Professional with 12+ years of experience in clinical
research industry who always excels at prioritizing,
completing multiple tasks simultaneously and aiming
to achieve project goals.
She brings extensive experiences in clinical operation
and regulatory field.
Dr. Raihana Amin, MD
Toronto, Canada
Dr. Raihana Amin, MD is the expert when it is about Gynaecology, aesthetics, dental, urology and medical imaging. She brings 20 years of clinical experiences that translates to the safety of medical device. She is our expert in clinical investigation
- Expert in the writing and assessment of Clinical Evaluation Report including CEP, literature search, Literature assessment and compiling CER
and PMCF - Demonstrated track record of International Regulatory Compliance – product authorizations, clearances, and approvals in different
geographies (European Union (EU) /US / Canada) - Extensive submission experiences in the US and EU – includes 510(k), PMA for US FDA; Design Dossier and Technical Files for EU
- Excels at strategizing and implementing action plans to address Regulatory hurdles (e.g., IVDR) and Quality challenges, in support of new
product introduction and maintenance of on-market products. - Possesses the communication skills needed to cultivate positive relationships with Notified Bodies, EU Competent Authorities, US FDA,
Authorized Representatives and global Regulatory agencies. In-depth understanding of technical and regulatory aspects of: - Lab Diagnostic products involving molecular technologies / bead-based immunoassays / homogeneous enzyme immunoassays / clinical
chemistry assays. - Software as Medical Device (SaMD) / non-invasive sensor-based Digital Health products.
- Experience with biomarker assays in oncology, infectious & inflammatory diseases, metabolic disorders, and cardiovascular diseases; blood
screening assays; Therapeutic Drug Monitoring (TDM) assays, Urine Drug Tests. - IVD Program Management => led cross-functional QMS, Design Control and product lifecycle initiatives involving R&D, QA / QC,
Manufacturing, Validation, Clinical Operations, Medical Affairs, Product Management, and Executive Leadership. - Developed, implemented, and managed processes and procedures to enable Manufacturing area QA / QC and Clinical Laboratory (CLIA)
Quality - In-depth knowledge of:
Regulation (EU) 2017/745 (MDR) | Regulation (EU) 2017/746 (IVDR) | SOR/98-282 (Health Canada) |Therapeutic Goods (Medical
Devices) Regulations 2002 (TGA Australia) | Medical Device Rules 2017 (CDSCO, India).
∙ US FDA Regulations: 21 CFR Parts 801, 803, 807, 809, 812, 814, 821, 822, 830, 860, 862, 864, 866, 870, 210, 211, 600.
∙ US FDA 21 CFR Part 11.
∙ ISO 11135, ISO 11137: Sterilization of health care products
∙ ISO 10993-1:2018: Biological evaluation of medical devices
∙ ISO 22442: Medical devices utilizing animal tissues and their derivatives
∙ ISO 13485:2016 | ISO 17025 | ISO 9001 | 21 CFR Part 820 | MDSAP Audit.
∙ ISO 14971:2019 | ISO/TR 24971 (Medical Device Risk Assessment).
∙ Clinical Investigation: Medical device: ISO 14155; Pharma: ICH GCP
∙ Regulatory Guidance documents from FDA, MDIC, IMDRF & MDCG | MEDDEV guidance documents (developed by working groups
on behalf of European Commission) | ICH Guidelines
∙ Pharmacovigilance: EU Volume 9b, Adverse Events, Directive 2001/82/EC