PROCESS
OF BIOPHARMA CONSULTING
RegSolutions is a consultancy company specialized in the global development, submission, approval and maintenance of biopharmaceuticals, including novel biologics, ATMPs, biosimilars and medical devices. We support your projects through to success. We support your projects through to success.
02
Registration
Navigating the complex landscape of regulations and approvals can be overwhelming. We make it simple by guiding you every step of the way.
03
Maintenance
Beyond compliance, we improve the performance of your biopharma with our comprehensive maintenance services.
01
Development
Our development process is tailored to your unique needs, ensuring the highest quality results and a faster path to market.
01
Development
Our development process is tailored to your unique needs, ensuring the highest quality results and a faster path to market.
20+
Years leading the way in the pharma industry
15+
Years mastering regulatory requirements
5+
Years delivering results-driven regulatory consulting
20+
Companies trust our regulatory expertise
Competence
- We provide expertise in developing, registering, and maintaining novel drugs(e.g. biopharmaceuticals, ATMPs) and biosimilars in both the EU and US.
- With our guidance, we'll coach, prepare and lead your meetings with EMA and FDA health authorities.
- Your global pharmaceutical partner.
- We provide worldwide support and access to M&A experts.
Flexibility
RegSolutions can support you when needed – where needed:
- Small to large outsourcing projects
- Customer on-site support
- Ad-hoc regulatory advice
- Maternity leave/paternity leave/sickness absence
THE VALUES THAT GUIDE OUR WORK
RegSolutions, founded in January 2019 by Vesna Schauer-Vukasinovic, Ph.D., is driven by our core values, shaping our approach to delivering exceptional results for our clients in the fast-paced world of biopharmaceuticals.
MEET OUR CORE TEAM
At RegSolutions, our team is composed of highly skilled professionals with experience in drug development and with contacts to experts in different fields of the pharmaceutical industry. Our collective expertise allows us to provide our clients with the best solutions and services for their pharmaceutical needs.
Ph.D., Founder and Principal Consultant
Vesna Schauer-Vukasinovic
Vesna is an Austrian national with over 20 years of experience in the pharmaceutical industry (multinational pharma and biotech companies), including 15 years in the area of regulatory affairs. She has regulatory and leadership expertise in development, registration and maintenance of biopharmaceuticals /mRNAs/biosimilars, with a focus on the EU and US and other highly regulated markets.
M&A Senior Consultant Consultant
Norbert Dreyer Norbert reyer
Norbert is a German national and has over 25 years of experience in the sourcing and execution of global crossborder corporate finance/M&A advisory deals. He worked in banking and in private equity in Europe and in the US before moving to Latin America in 2005 where he is a Partner of a regional investment banking boutique also with a strong focus on the life sciences sector.
Global pharmaceutical companies developing:
Biosimilars
Advance Therapy Medicinal Products (ATMPs)
Novel biologics (including orphan designations)
WHOM WE SERVE
M&A DUE DILIGENCE
-
The sourcing and execution of global cross-border corporate finance / M&A advisory deals.
-
Due diligence activities by reviewing and analysing relevant development- and licensure-related documents.
REGULATORY
-
Regulatory leadership and expertise in development, approval and maintenance of biosimilars (hormones, mAbs, fusion proteins), mRNA/CAR-T cell-based oncology immunotherapies, rare diseases and other biologics.
-
Regulatory support of clinical trials, phase I – IV.
-
Leadership in coordination, preparation, and submission of briefing book, CTA, IND, iPSP, PIP, DMEPA, BLA, J-NDA and MAA.
-
Coordination of health authority interactions.
OUR SERVICES
RegSolutions provide tailored consulting services and operational execution for our pharmaceutical partners.