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RegPak BioPharma Consulting
RegPak BioPharma (RegPak) is a full service Regulatory Affairs (RA), Pharmacovigilance (PV) and Quality Assurance (QA) Consultancy, whose mission is to provide high quality services within RA, PV, Quality and EU Batch Release to the pharmaceutical and life sciences industries.
Clients include pharma, biotech, medical device, veterinary, herbal supplement, homeopathic and nutraceutical companies.
RegPak BioPharma’s culture is based on four major components: Quality, Global Reach, Confidentiality and Transparency. Together, these shape the consultancy’s relationships with principals and customers and define its internal organization.
Activities and Capabilities
RegPak’s activities are centered on RA, PV, QA, Batch Testing & Product Release, Medical Writing, Audits, Clinical Research, Medical Device Consulting, CE Marking, Parallel Import and Distribution.
RegPak’s core competence is its ability to apply increasingly complex best practice models, standards and regulations to deliver significant value to its clients, based on thorough knowledge and understanding of directives and guidelines issued by ICH, the European Medical Agency (EMA), US and other authorities.
RegPak has extensive experience dealing with orphan drug applications and expanded access/named patient programmes.
It has Clinical Trial Administration (CTA) expertise covering the EU, EEA/ Central & Eastern Europe, Switzerland, Turkey, and Ukraine, North America (FDA), LatAm, Asia Pacific, Israel and South Africa. It has similar geographic spread for Marketing Authorization Application (MAA) expertise.
RegPak therapeutic expertise covers a wide range of disciplines and indications, including Oncology, CNS (Migraine, Parkinson’s Disease, Alzheimer’s, Neuropathic Pain and MS), Rheumatoid Arthritis (incl. Psoriatic Arthritis), Gout, IBD (Crohn’s disease and Ulcerative colitis), Renal Disorders (Renal Biopsy, Transplantation, A Amyloidosis and Incontinence), Asthma/COPD, Dermatology, Allergy, Diabetes and Infectious Diseases (Hepatitis B, HCV & Otitis Media).
Products & Services
RegPak’s high quality consultancy services cover Regulatory Affairs, Licensing and Technical Services, Pharmacovigilance, Auditing (GxP), Batch Testing & Release, Importation and Warehousing.
In Regulatory Affairs, RegPak can provide developed services covering Strategic Planning for Product Development, Scientific Data Assessment, Registration, International Regulatory Desk Research, Clinical Consultancy, Publishing and Submission Management, Medical Devices, Product Literature, Readability Testing and Nutritional and Food Supplements registration.
Its global Drug Safety/Pharmacovigilance service combined with specific consultancy and assistance throughout product development and marketing life cycle to meet client PV needs including Safety Reporting, Writing Risk Minimization Plans, PV Plans, Benefit and Risk Assessment, PSUR/DSUR and PV System Master File (PSMF).
Company history and structure
RegPak Biopharma was founded in September 2008 by its current CEO, Parminder Kaur, who was named Sikh Businesswomen of the Year (2014) and gained the International Indian Achiever’s Award (2019). Since then it has expanded its consultancy services to a full range of Regulatory Affairs and related fields.
Mrs. Kaur has also led the European Commission supported IMI Initiative for combination therapy.
RegPak has also expanded its geographic presence to include a Central European office in Romania and local operations in India.
Quality, Regulatory and Standards
RegPak strictly follows EU regulations pertaining to consultancy services being offered to clients and rigorously adheres to country-specific norms when operating outside the EU.
Its internal quality management systems meet international standards and have been audited by clients.
RegPak’s rigorous standard operating procedures (SOPs) and QC policies are subject to internal audit.
RegPak BioPharma Consultancy S.R.L.
17, C.A Rosetti, 2nd District,
Bucharest, 011469, Romania