RegPak Biopharma

About RegPak Biopharma

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

Keywords

• Batch Testing & Release Services
• Anda
• Assistance With Parallel Import/Wharehousing/Importation
• B
• Batch Testing & Release Services
• Biologics & Biosimilars
• Bla
• Clinical Regulatory Writing
• Corporate Training
• Food Supplements
• Generics
• Herbal Medical Products
• Marketing Authorization
• Medical & Regulatory Writing
• Medical Devices
• Nces
• Nda
• Pharmaceutical Filings
• Pharmocovigelence
• Quality Assurance Services
• Regulatory Affairs Consultancy

Address

• Headquarters

  Aristotelesstraat 18, 1064 LD1064 AmsterdamNoord-Holland, Netherlands