Find services providers, consultants and freelancers for Regulatory Strategy Services. The list does not claim to be complete and no guarantee can be given for the correctness and up-to-dateness of the information provided. Furthermore, please note that this list does not have any recommendatory character.
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Saidia Pharma Service Limited
Bei den Mühren 66a
Dr. Michael Klein
Michor Consulting and Trade Services GmbH
ProPharma Group GmbH
Telefon: 030/856 06878-0
ProPharma Group GmbH is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare.
Contact us in any phase of your product's lifecycle if you are looking for a partner in Product Development, Regulatory Affairs, (Pharmaco)vigilance or QA/QC.
ERA Consulting GmbH
Lange Strasse 70
Tel: # 49 (0) 5161 9890 0
Fax: # 49 (0) 5161 9890 18
ERA Consulting is a strategic regulatory consultancy for products such as vaccines, personalised medicine products, novel mAb's, biosimilars, complex proteins, cell and gene therapies, gene editing, regenerative medicine and NCE’s. ERA’s expert consultants are providing support ranging from strategic input, agency interactions, through to the management and writing of dossiers for marketing authorisation and electronic submission and interactions with various regulatory agencies such as EMA (including all National Agencies), FDA, PMDA, TGA, Health Canada and Swiss Medic.
As our team and associates were previously from Agencies, our expertise in submission and registration is a pivotal area. Apart from the regular services of submission in its simplest form, Pharmexon is able to provide ongoing strategy and inputs during the process. Our team understands that Agencies are made up of individuals and opinions can vary. Depending on the source of the query we can assist understanding the root cause of such deficiencies and assist in responding, negotiating or even deferring responses to the agencies. We can also assist in making decisions with regards to withdrawals or resubmissions, particularly in the light of transparency laws that currently exist. Our team is also experienced in leveraging other successful MA grants in other parts of the globe to assist in Agencies to make decisions in their own assessments.
Some of the services offered in this area are:
PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.
We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.
The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.
Head Office address:
20 The Causeway
Bishop’s Stortford, Hertfordshire,
Tel: +44 (0)1279 656 305
Scendea (NL) B.V.
De Cuserstraat 93
1081 CN Amsterdam
Tel: +31 (0)208 949 169
Scendea (USA) Inc.
5764 Pacific Center Blvd.
San Diego, CA 92121
Tel: +1 619 793 4511
Fax: +1 858 295 1477
Scendea is a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. We are committed problem solvers, redefining the meaning of customer service, with a focus on reducing time-to-market and minimising development costs. A combination of scientific excellence, industry experience and a collaborative approach enable us to deliver high-quality innovative solutions, which allow our clients to succeed. Our international team offers strategic and operational support in the fields of quality/CMC, non-clinical/toxicology, clinical/medical and regulatory, which guide products efficiently from early development to marketing approval.