Project
Planning
DSSPL team is fully conversant with the principles
of project planning and is skilled in the art of preparing
elegant plans using latest Project software.
DSSPL Team assess the existing data package, after
a client’s briefing to determine whether the
studies conducted to date, or planned, will meet the
scientific and regulatory requirements of the target
territories.
Further, the actions necessary to complete the development
programme are defined and arranged in order of precedence.
The interrelationships between tasks are linked, having
regard to the client’s preference for an aggressive
or low risk approach, to create a PERT network which
defines the critical path and time to launch.
For each task, resource is allocated either from in-house
personnel or subcontractors for an efficient development
programme. When the client is satisfied with the logic
and timings of the draft plan, the programme is costed
and this allows cashflow projections to be generated
for the whole project or any part of it. In this way
the client can predict when capital funding is required
or adjust the plan to meet current commitments.
DSSPL has handled many regulatory submissions,
in different countries, on behalf of client companies.
These include Gap analysis of dossier, product development
CTD dossier, Analytical method validation, Bio-wavier
documentation, Documents review / assembly / compilation
and submission for marketing authorizations.
DSSPL can provide services in many ways:
•
Assessment
of data for suitability for registration
•
Identification
of deficiencies
•
Recommendation of Rapporteur and Co-rapporteur
•
Provides regulatory due diligence for potential
licensing opportunities in chemistry, manufacturing
and control, preclinical and clinical research
•
Preparation of marketing authorisation application
•
Submission of dossier and payment of fees
•
Assuring validation of the dossier
•
Receiving questions and preparation of suitable
responses
•
Co-ordination and submission of responses
•
If necessary, arranging an oral explanation,
accompanying the client
•
Organising final translations of SPC, PIL and
labels in all official languages
•
Submission of colour mock-ups.
•
Expert Reports / Overviews
•
Literature search
DSSPL team is qualified to advise on all the scientific
disciplines required for successful registration in
the EU and other territories. The team's vast regulatory
experience includes many approvals via both Decentralised
and MR routes.
We have established excellent working
relationships with translators and reprographics companies
to ensure high quality dossiers meeting EU requirements.
We also understand the importance of prompt and secure
dispatch of dossiers to the authorities.
Our extensive experience allows us to advise
on the submission route and success factors in getting
the application right first time.
The activities we cover are listed below:
•
Comparison of Summaries of Product Characteristics
•
Organisation
of meeting with Reference Member State, accompanying
the client
•
Updating the dossier including Expert Reports/Overviews,
if necessary
•
Obtaining the Assessment Report from the RMS
•
Arranging translations and preparing documentation
for each Concerned Member State
•
Organising payment of fees
•
Co-ordination of pagination, photocopying, binding,
and dispatch of dossier to the authorities
•
Assuring validation and clock start
•
Collecting questions from the authorities and
preparation of responses
•
Co-ordination and submission of responses and
liaison with the authorities until grant of
marketing authorisation
•
Clarification of concerns and deficiencies at
MRFG/Co-ordination Group
•
Preparation and submission of mock-ups for finalised
Patient Information Leaflet and labels
•
Advice on arbitration process
DSSPL can provide services to companies for Identification
of worldwide regulatory requirements. Our team shall
provide up-to-date guidance on regulatory requirements
for products under development, as
it is difficult for companies to be totally aware
of all the regulatory requirements worldwide for every
type of product.
