P&P Solar offers a comprehensive consultancy and administrative services in Health Regulation, in order that our clients may outsource a Regulatory Affairs Department, to assist in all or some of the following regulatory activities that are part of a registered product’s lifecycle:
As part of these services, P&P Solar has enough experience to help you to assess the formulation of your product and to determine its regulatory classification; i.e. if your product will be considered as a drug product, a medical device, a cosmetic, a food or a food supplement.
Once determined the regulatory classification of your product, our teamwork may assist you to determine the corresponding registration requirements for marketing your product, as well as to determine the most suitable COFEPRIS approval pathway and timeline; i.e. if your product will require a notification or a MA submission.
As soon as your company receives the registration source documents from the manufacturer of your product; P&P Solar may support you to assess such data to ensure its completeness for marketing approval.
Our teamwork may also help you to develop and/or assess your product’s labeling in order to guarantee its compliance with applicable health regulations.
Likewise, P&P Solar may assist you to evaluate and request approval from COFEPRIS for the advertising campaigns of your products.
Our teamwork has the experience to help you to plan, coordinate and request import licenses for your products (if applicable), by scheduling and controlling the new applications and renewals.
Therefore, the P&P Solar staff may assist you to plan, coordinate and submit Pharmacovigilance, Technovigilance reports, as well as Risk Management Plans; by scheduling, submitting and controlling the corresponding PSURs, Pharmacovigilance and Technovigilance reports, these two latter required for MAA’s renewal.
In the same way, our teamwork has broad experience to help you planning and coordinating MAA’s renewals; by scheduling and controlling them, ensuring uninterrupted marketing of your products.
Finally, in case of need, the P&P Solar team may support you to request a MAA cancellation, if your company is not more interested in renew it.
If your product requires a MAA, P&P Solar may assist you to determine the corresponding registration requirements; as well as to determine the most suitable COFEPRIS approval pathway and timeline; i.e. if your company may choose from an ordinary MA, a MA with pre-approval (Positive Technical Report) or a MA under an Equivalence Recognition Agreement.
Our teamwork may help you to evaluate and perform a gap analysis of your registration source data; in order to guarantee its completeness for MA approval.
From the complete registration source data, in original language and the corresponding translation into Spanish; P&P Solar may support you to compile the needed information, write and tailor the corresponding MA file, until deliver to your company a printed version ready for submission before COFEPRIS in total compliance with current registration requirements, i.e. an indexed, numbered, printed dossier in binders with dividers, duly signed and labelled; as well as an electronically version in a PDF format for your files.
Our teamwork has broad experience in the preparation of MA files for the following kind of Drug Products: :
P&P Solar teamwork has broad experience in the preparation of MA files for the following kind of Medical Devices class Ia, I, II or III:
P&P Solar has the knowledge and broad expertise to support you with applications before COFEPRIS for Drug products, Medical Devices, Food Supplements, Food and Beverages, Cosmetics and similar products, such as:
Day to day contact of P&P Solar staff with processes and procedures of COFEPRIS, has given us the expertise to support you as authorized representatives of your company before COFEPRIS; in such a way we may assist you with:
Remark: COFEPRIS fee should be paid by the applicant, otherwise reimbursed to P&P Solar, accordingly.
In this way, we integrate the administration task in our services in order to your company does not spend time going back and forth and standing at COFEPRIS offices, waiting long periods of time; allowing your staff to invest its time in what really matters for your company: your consumers and their health.
P&P Solar team has the ability and broad experience to identify and select the data for MA that needs to be translated into Spanish.
Likewise, P&P Solar works with a group of independent translators and translation companies, validated by P&P Solar to assist your company in this task. In this way, P&P Solar may help you to coordinate translations into Spanish of the MA data, either simple or expert translation, integrating this task in our portfolio of services in order to support your company to avoid the need to qualify and register additional suppliers.
REMARK: This service is quoted by separated with the translators we work with, previous agreement with the client.
P&P Solar team has the ability and broad experience to identify and select the data for MA that needs to be provided as certified copy by a notary.
Therefore, P&P Solar works with a group of independent notaries, validated by P&P Solar to help you company in this task. In this way, P&P Solar may support you to coordinate certifications before notaries of the legal data intended for MA. Then, we integrate this task in our portfolio of services in order to assist your company to avoid the need to qualify and register additional suppliers
Our team has the ability and experience to help your company with legalization and apostille procedures of legal documents intended for registration abroad, since P&P Solar knows this process and may support you with the coordination of this procedure. Then, we integrate this task in our portfolio of services in order to assist your company to avoid the need to qualify and register additional suppliers.
P&P Solar has the knowledge and broad expertise to support you with requesting pre-approvals (Positive Technical Reports) from Third-Party Notified Bodies (TPNB) for drug products and medical devices, since has collaborated with several TPNBs currently approved by COFEPRIS and is aware of their working procedures.
In this way, P&P Solar may help you with the coordination of this task since the execution of the Service’s Agreement between the client and the TPNB, until the Positive Technical Report’s granting. Then, we integrate this task in our portfolio of services in order to assist your company to avoid the need to additional administration processes.
REMARK: This service is quoted by separated with the TPNB we work with, previous selection and agreement with the client.
P&P Solar has the experience and has participated in implementing several Pharmacovigilance and Technovigilance Units. In this way, our team may support your company to develop and implement the required Standard Operating Procedures by current health legislation, in order to comply with requirements of standards NOM-220 and NOM-240.
Likewise, derived from new regulations related to good manufacturing practices for medical devices and food supplements; P&P Solar has participated in developing and implementing Quality Managements Systems for medical devices and food supplements companies, in order to help them to comply with requirements of standards NOM-241 and NOM-251.
Our teamwork knows and has broad experience in the applicability of local health regulation. Therefore, P&P Solar integrates this service to support your company to identify new regulations, or changes in current health legislation that may have an impact on the activities of your company.
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