RegPak BioPharma is an Amsterdam based full service Regulatory Affairs Consultancy with the key objective of providing high quality services within Regulatory Affairs, Licensing and Technical Services to the industries. We provide consistent superiority, reliability and accountability. When you deal with us, you can be sure of detailed project management and the highest standards. Quality and cost management are the threads that bind us together.
Our emphasis is on consulting relating to quality, nonclinical and clinical aspects, both from the perspective of development strategy and regulatory requirements. RegPak BioPharma has the knowledge and experience to assist at all stages of product development, from conception to registration, and beyond.
Our expertise covers a wide range of products including products of recombinant DNA and hybridoma technology, synthetic peptides, conventional and advanced vaccines, classical blood products, advanced therapy medicinal products e.g., nanotechnology based products and drugs with novel drug delivery technology.
SERVICES:
1) Regulatory Affairs consultency
(Regulatory strategy, Gap analysis, Dossier compilation & Submissions, Marketing Authorization, Scientific Advice, Label compliance, Clinical trail labelling).
2) Pharmaceutical Filings NCEs, Generics, Biologics & Biosimilars, Medical Devices, Herbal Medical products, Food Supplements.
3) Pharmacovigelence Services.
4) Batch Testing & Release Services.
5)Quality Assurance Services.
6)Assistance with parallel import/wharehousing/Importation.
7)Medical & Regulatory Writing.
8) Corporate Training.
Please reach us for any Inquiry @
Parminder Kaur (CEO)
Email: parminder@regpakbiopharma.com
Business Development
Sharath K
Email: sharath@regpakbiopharma.com
Company Details
- Employees
- 13
- Founded
- -
- Address
- Aristotelesstraat 18, 1064 Ld, Amsterdam,north Holland 1064,netherlands
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- regpakbiopharma.com
- Keywords
- Regulatory Affairs Consultancy, Pharmocovigelence, Batch Testing & Release Services, Quality Assurance Services, Assistance with parallel import/wharehousing/Importation, Medical & Regulatory Writing, Corporate Training, Pharmaceutical Filings, NCEs, Generics, Biologics & Biosimilars, Medical Devices, Herbal Medical products, Food Supplements, ANDA, NDA, B, BLA, Marketing Authorization, Clinical Regulatory Writing.
- HQ
- Amsterdam, North Holland
Regpak Biopharma Questions
Regpak Biopharma's website is regpakbiopharma.com
Regpak Biopharma's LinkedIn profile is https://nl.linkedin.com/company/regpak-biopharma
Regpak Biopharma has
13 employees.
View email and phone details for 13
employees at Regpak Biopharma.
Regpak Biopharma's industry is
Pharmaceutical Manufacturing
Regpak Biopharma's top competitors are
Scenic Biotech,
Kling Biotherapeutics,
Linxis Biopharmaceuticals,
Cognizant,
Ashcure Pharma B.v.,
Parexel,
Koncord Clinical Research Services,
Excelya,
Productlife Group,
Viatris.
Regpak Biopharma's categories are Pharmaceutical Manufacturing
Regpak Biopharma's founding year is 2008
