Regulatory Strategy

• Scientific Advice
• Paediatric Investigations Plans (PIP)
• Regulatory Roll-out Strategy
• Monitoring des regulatorischen Umfelds
• Due Dilligence

• Consulting in drug development
• Clinical trials / INDs
• Regulatory Strategy
• Communication with authorities
• Orphan drug designations
• Scientific Advice preparations (US, EU, PMDA, etc.)
• Pediatric plan and development

• Scientific Advice SA, Clinical Trial Application CTA, Marketing Authorisation Application MAA (NP, DCP, MRP)
• evaluation of existing documentation, gap analysis, development plan for new products and in life cycle
• review of regulatory status (approvals, variations, countries) 
• gap analysis and draft regulatory strategy based on product idea and document review 
• evaluation of variation strategy 
• review of existing dossiers (due diligence)

• Formulate the right strategy at the start (first time right) 
• Ensure regulatory input during your drug development programmes 
• Reduce the time to market by choosing the right strategy 
• Ensure compatibility with business expectations 
• Meet submission deadlines 
• Review regulatory information during a merger or acquisition 
• Review regulatory information before buying new products 
• Reviewing pharmacovigilance and complaints data 
• Check for compliance 
• Initiate contact with the relevant authorities
• Prepare briefing packages
• Moderate authority meetings

• Authorisation strategy consulting for human and veterinary medicinal products 
• Gap analysis
• Preparation and supervision of scientific advice
• Due diligence:
  o Marketing authorisation documents (medicinal products)
  o Technical documentation (medical devices)
  o Product information files (cosmetics)
  o Documents required under food law (food supplements)
  o Status of ongoing procedures (applications, variations, conformity assessments, etc.)
  o Status of clinical documentation and, where applicable, any ongoing clinical studies, tests or evaluations
  o Quality management (GMP/GDP, ISO 13485, HACCP) and vigilance
  o Regulatory evaluation with regard to the further life cycle
• DiapharmKlick: the latest overview of new OTC products in Germany, Austria, Spain, France, the United Kingdom and the US

• Consulting on Scientific Advice (national, EMA, FDA)
• Assistance with arranging scientific advice meetings with agencies
• Consulting on an appropriate regulatory strategy for filings
• Review and assessment of regulatory documents
• Due diligence - evaluation of medicines offered for in-licensing 
• Review or generation of business case presentations for partnering and out-licensing

• Development strategy
• Regulatory consulting
• Submission plan
• CMC
• Quality
• Regulatory Intelligence
• Gap Analysis
• GxP Compliance
• Due diligence

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. 

• Regulatory Strategy & Intelligence
• RA-Clinical
• Scientific Advice Support

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:

• Fully compliant dossier submission in most regulated regions
• Support (technical, administrative and regulatory) for Deficiency response and      coordination
• Facilitation of dialogue with Agencies during registration process
• Support of finalisation of procedure/national phase
• Management of referrals - regulatory and scientific
• Troubleshoot/risk assessment of major concerns - strategy adaptation
• Finalisation of critical texts for marketing purposes
• Assistance in accepting/rejecting post-approval commitments
• Assistance in GMP Inspections, CAPA and communication with Inspectors
• Place predictors in place on Agency feedback on aspects of Quality, Clinical and Preclinical
• Suggest truncation of programs based on other similar developments
• Create briefing packages and facilitate meetings for Scientific Advice
• Due Diligence of pre-development of formulations for CMC/Quality aspects - small and large molecules
• Vaccine and biotech development challenges (ie process, upstreaming, program design)
• Informal opinions from regulatory network
• Map out the entire regulatory process, with possible timelines, including detailed Scientific Criteria for the product type (including GxP, manufacturing, documentation, clinical and preclinical programs)
• Qualification of production of API and FP - GMP pre-audit of sites (API/GMP)

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.

• Regulatory Strategy
• Regulatory Intelligence
• Regulatory Intelligence Scientific Advice Support
• Health authority interactions
• Development strategy

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.

• Regulatory Strategy for new MAAs and existing MAs (EU)
• Scientific Advice Support
• Regulatory Due Diligence
• Regulatory Compliance and SWOT-Analysis